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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05934422
Registration number
NCT05934422
Ethics application status
Date submitted
4/05/2023
Date registered
7/07/2023
Titles & IDs
Public title
NiPPeR Randomised Trial - Child Follow Up Study
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Scientific title
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health - Child Health and Well-being Follow Up Study
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Secondary ID [1]
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0
79093
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Universal Trial Number (UTN)
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Trial acronym
NiPPeR Child
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity, Childhood
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0
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Cognition
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0
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Neurobehavioral Manifestations
0
0
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Metabolic Disturbance
0
0
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Growth Disorders
0
0
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Allergy
0
0
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Atopic Dermatitis
0
0
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Atopy
0
0
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Nutrition, Healthy
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0
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Lifestyle
0
0
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Microbial Colonization
0
0
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Breastfeeding
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Studies of infection and infectious agents
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Infection
0
0
0
0
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Other infectious diseases
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Infection
0
0
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0
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Sexually transmitted infections
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Neurological
0
0
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0
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Other neurological disorders
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Skin
0
0
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0
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Dermatological conditions
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Skin
0
0
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0
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Other skin conditions
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Diet and Nutrition
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0
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0
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Obesity
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Musculoskeletal
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0
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0
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Other muscular and skeletal disorders
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Metabolic and Endocrine
0
0
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0
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Other endocrine disorders
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Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Intervention (Study Nutritional Drink)
Other interventions - Control (Standard Nutritional Drink)
Experimental: Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy - NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception \& pregnancy
Active comparator: Prior Control - standard micronutrients in preconception & pregnancy - NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception \& pregnancy
Other interventions: Intervention (Study Nutritional Drink)
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
Other interventions: Control (Standard Nutritional Drink)
Control nutritional drink containing a standard mix of micronutrients
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Child Body Mass Index (kg/m2), derived from weight and height
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Assessment method [1]
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Child size and body composition
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Timepoint [1]
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Up to age 8 years, from periconception to age 8 years
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Primary outcome [2]
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Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
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Assessment method [2]
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Child cognition
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Timepoint [2]
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Up to age 8 years, from periconception to age 8 years
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Primary outcome [3]
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Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
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Assessment method [3]
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Child insulin resistance
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Timepoint [3]
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Up to age 8 years, from periconception to age 8 years
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Primary outcome [4]
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Dimensional Change Card Sort Test (raw & T-scores)
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Assessment method [4]
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Child executive functioning - NIH Toolbox Cognition Battery component
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Timepoint [4]
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Up to age 8 years, from periconception to age 8 years
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Primary outcome [5]
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Flanker Inhibitory Control & Attention Test (raw & T-scores)
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Assessment method [5]
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Child executive functioning - NIH Toolbox Cognition Battery Component
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Timepoint [5]
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Up to age 8 years, from periconception to age 8 years
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Primary outcome [6]
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Strengths & Difficulties Questionnaire score (no units)
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Assessment method [6]
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0
Child neurobehavioural functioning
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Timepoint [6]
0
0
Up to age 8 years, from periconception to age 8 years
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Primary outcome [7]
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0
Child Behaviour Check List score (no units)
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Assessment method [7]
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0
Child neurobehavioural functioning
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Timepoint [7]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [1]
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0
Body fat mass (kg, % and indices)
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Assessment method [1]
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0
Obesity and body composition
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Timepoint [1]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [2]
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0
Change in body fat mass (kg)
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Assessment method [2]
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0
Adiposity gain
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Timepoint [2]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [3]
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0
Body lean mass (kg, % and indices)
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Assessment method [3]
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Child body composition - lean mass
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Timepoint [3]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [4]
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0
Change in lean mass (kg)
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Assessment method [4]
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0
Lean mass gain
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Timepoint [4]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [5]
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0
Body bone mass (kg, % and indices)
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Assessment method [5]
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Child body composition - bone mass
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Timepoint [5]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [6]
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Change in bone mass (kg)
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Assessment method [6]
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Bone mass gain
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Timepoint [6]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [7]
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0
Child height (cm)
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Assessment method [7]
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Child height
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Timepoint [7]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [8]
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0
Height growth (cm)
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Assessment method [8]
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Linear growth
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Timepoint [8]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [9]
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0
Change in body mass index (z-score & percentile)
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Assessment method [9]
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Change in BMI
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Timepoint [9]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [10]
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0
Change in weight (kg)
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Assessment method [10]
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0
Weight gain
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Timepoint [10]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [11]
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0
Child mid-upper arm circumference (cm)
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Assessment method [11]
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Child arm circumference
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Timepoint [11]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [12]
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0
Change in mid-upper circumference (z-score)
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Assessment method [12]
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Change in soft tissue mass
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Timepoint [12]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [13]
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0
Child waist circumference (cm)
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Assessment method [13]
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Child waist circumference
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Timepoint [13]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [14]
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0
Change in waist circumference (z-score)
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Assessment method [14]
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0
Adiposity gain
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Timepoint [14]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [15]
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0
Heart rate response to step test (beats per minute)
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Assessment method [15]
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Cardiovascular fitness and function
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Timepoint [15]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [16]
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0
Child blood pressure (mm Hg)
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Assessment method [16]
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Cardiovascular fitness and function
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Timepoint [16]
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Up to age 8 years, from periconception to age 8 years
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Secondary outcome [17]
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0
Child resting heart rate (beats per minute)
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Assessment method [17]
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0
Cardiovascular fitness and function
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Timepoint [17]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [18]
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0
Child minutes to return to resting heart rate (minutes)
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Assessment method [18]
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0
Cardiovascular fitness and function
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Timepoint [18]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [19]
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0
Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing
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Assessment method [19]
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0
Child health and wellbeing
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Timepoint [19]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [20]
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0
Dietary patterns ascertained by frequency questionnaires
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Assessment method [20]
0
0
Child diet
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Timepoint [20]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [21]
0
0
Child Eating Behaviour Questionnaire
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Assessment method [21]
0
0
Child eating behaviours
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Timepoint [21]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [22]
0
0
Parental Feeding Practices Questionnaire
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Assessment method [22]
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0
Parental feeding practices
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Timepoint [22]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [23]
0
0
Children's Sleep Habits Questionnaire
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Assessment method [23]
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0
Child sleep patterns
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Timepoint [23]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [24]
0
0
Children's actigraphy measurements of activity behaviours [minutes/day]
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Assessment method [24]
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0
Child physical activity, sleep and sedentary behaviours
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Timepoint [24]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [25]
0
0
Child Movement Behaviour Questionnaire
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Assessment method [25]
0
0
Child activity behaviours
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Timepoint [25]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [26]
0
0
Skin pricks test results to allergens [mm]
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Assessment method [26]
0
0
Child atopic sensitisation
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Timepoint [26]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [27]
0
0
Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires
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Assessment method [27]
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0
Child atopic and allergic wellbeing and disorders
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Timepoint [27]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [28]
0
0
Hair metabolome panel concentrations (pmol/L)
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Assessment method [28]
0
0
Biomarkers of health and wellbeing measured in hair samples
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Timepoint [28]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [29]
0
0
Urine micronutrient concentrations (nmol/L)
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Assessment method [29]
0
0
Child micronutrient status
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Timepoint [29]
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0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [30]
0
0
Blood micronutrient concentrations (nmol/L)
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Assessment method [30]
0
0
Child circulating micronutrient profile
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Timepoint [30]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [31]
0
0
Blood trace element concentrations (pmol/L)
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Assessment method [31]
0
0
Child circulating trace element profile
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Timepoint [31]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [32]
0
0
Urine trace element concentrations (pmol/L)
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Assessment method [32]
0
0
Child trace element status
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Timepoint [32]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [33]
0
0
Stool metagenomic profile (abundance)
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Assessment method [33]
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0
Child gut microbiota composition
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Timepoint [33]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [34]
0
0
Skin metagenomic profile (abundance)
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Assessment method [34]
0
0
Child skin microbiota composition
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Timepoint [34]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [35]
0
0
Stool metatranscriptomic profile (relative activity)
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Assessment method [35]
0
0
Child gut microbiota activity profile
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Timepoint [35]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [36]
0
0
Skin metatranscriptomic profile (relative activity)
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Assessment method [36]
0
0
Child skin microbiota activity profile
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Timepoint [36]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [37]
0
0
Stool metabolomic profile (pmol/L)
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Assessment method [37]
0
0
Child gut microbiota metabolite profile
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Timepoint [37]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [38]
0
0
Skin metabolomic profile (pmol/L)
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Assessment method [38]
0
0
Child skin microbiota metabolite profile
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Timepoint [38]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [39]
0
0
Blood molecular profile (% methylation)
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Assessment method [39]
0
0
Child blood epigenetic profile
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Timepoint [39]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [40]
0
0
Buccal molecular profile (% methylation)
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Assessment method [40]
0
0
Child buccal cell epigenetic profile
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Timepoint [40]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [41]
0
0
Blood transcriptomic profile (relative expression)
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Assessment method [41]
0
0
Child blood transcriptomic profile
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Timepoint [41]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [42]
0
0
Buccal transcriptomic profile (relative expression)
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Assessment method [42]
0
0
Child buccal cell transcriptomic profile
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Timepoint [42]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [43]
0
0
Genetic variation (DNA sequence analysis)
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Assessment method [43]
0
0
Genetic variant analysis
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Timepoint [43]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [44]
0
0
Circulating chemocytokine measurements (nmol/L)
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Assessment method [44]
0
0
Child chemocytokine profile
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Timepoint [44]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [45]
0
0
Circulating adipokine measurements (nmol/L)
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Assessment method [45]
0
0
Child adipokine profile
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Timepoint [45]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [46]
0
0
Circulating inflammatory marker measurement (nmol/L)
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Assessment method [46]
0
0
Child inflammatory factor profile
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Timepoint [46]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [47]
0
0
Plasma glucose concentration (mmol/L)
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Assessment method [47]
0
0
Child's plasma glycemia
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Timepoint [47]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [48]
0
0
Plasma lipid concentrations (mmol/L)
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Assessment method [48]
0
0
Child's metabolic profile - lipid concentrations
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Timepoint [48]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [49]
0
0
Plasma high-sensitivity C-reactive protein concentrations (mmol/L)
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Assessment method [49]
0
0
Child's inflammatory marker status
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Timepoint [49]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [50]
0
0
Blood metabolome panel concentrations (pmol/L)
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Assessment method [50]
0
0
Child's blood metabolomic status
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Timepoint [50]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [51]
0
0
Urine metabolome panel concentrations (pmol/L)
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Assessment method [51]
0
0
Child's urine metabolomic status
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Timepoint [51]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [52]
0
0
Urine measurement of environmental pollutant exposure (pmol/L)
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Assessment method [52]
0
0
Urine exposome pollutant profile
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Timepoint [52]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [53]
0
0
Blood measurement of environmental pollutant exposure (ng/gm lipid)
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Assessment method [53]
0
0
Blood exposome pollutant profile
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Timepoint [53]
0
0
Up to age 8 years, from periconception to age 8 years
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Secondary outcome [54]
0
0
Hair measurement of environmental pollutant exposure (pmol/L)
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Assessment method [54]
0
0
Hair exposome pollutant profile
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Timepoint [54]
0
0
Up to age 8 years, from periconception to age 8 years
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Eligibility
Key inclusion criteria
All children still participating in the NiPPeR study at 6-8 years.
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Minimum age
6
Years
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Maximum age
8
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2026
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Actual
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Sample size
Target
510
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
New Zealand
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State/province [1]
0
0
Auckland
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Country [2]
0
0
Singapore
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State/province [2]
0
0
Singapore
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Country [3]
0
0
United Kingdom
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State/province [3]
0
0
Hampshire
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Southampton
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
National University Hospital, Singapore
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Commercial sector/industry
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Name [2]
0
0
Auckland UniServices Ltd.
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Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
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Name [3]
0
0
Institute for Human Development and Potential (IHDP), Singapore
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Address [3]
0
0
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Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
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Name [4]
0
0
National University of Singapore
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Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Other
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Name [5]
0
0
National University Health System, Singapore
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Address [5]
0
0
Query!
Country [5]
0
0
Query!
Other collaborator category [6]
0
0
Other
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Name [6]
0
0
University of Auckland, New Zealand
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Address [6]
0
0
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Country [6]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms. This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms. The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.
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Trial website
https://clinicaltrials.gov/study/NCT05934422
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Trial related presentations / publications
Godfrey KM, Cutfield W, Chan SY, Baker PN, Chong YS; NiPPeR Study Group. Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial. Trials. 2017 Mar 20;18(1):131. doi: 10.1186/s13063-017-1875-x. Godfrey KM, Barton SJ, El-Heis S, Kenealy T, Nield H, Baker PN, Chong YS, Cutfield W, Chan SY; NiPPeR Study Group. Myo-Inositol, Probiotics, and Micronutrient Supplementation From Preconception for Glycemia in Pregnancy: NiPPeR International Multicenter Double-Blind Randomized Controlled Trial. Diabetes Care. 2021 May;44(5):1091-1099. doi: 10.2337/dc20-2515. Epub 2021 Mar 29.
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Public notes
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Contacts
Principal investigator
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Wayne S Cutfield, MB MD FRACP
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The University of Auckland
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05934422