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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05033483




Registration number
NCT05033483
Ethics application status
Date submitted
13/08/2021
Date registered
2/09/2021

Titles & IDs
Public title
Do Iron Supplements Impact the Gut Microbiome of Women of Reproductive Age?
Scientific title
Do Iron Supplements Impact the Gut Microbiome of Women of Reproductive Age?
Secondary ID [1] 0 0
Iron Mic
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron-deficiency 0 0
Microbial Colonization 0 0
Anemia 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ferrous Fumarate
Treatment: Other - Placebo

Experimental: Iron Supplement - 65.7 mg of iron as ferrous fumarate

Active comparator: Placebo - 0 mg of iron


Treatment: Other: Ferrous Fumarate
Gelatin capsule containing 200 mg ferrous fumarate and microcrystalline cellulose

Treatment: Other: Placebo
Gelatin capsule containing microcrystalline cellulose
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Weighted UniFrac dissimilarity score
Timepoint [1] 0 0
21 days
Secondary outcome [1] 0 0
Bray-Curtis dissimilarity score
Timepoint [1] 0 0
21 days
Secondary outcome [2] 0 0
Shannon Wiener Diversity
Timepoint [2] 0 0
21 days
Secondary outcome [3] 0 0
Faith's phylogenetic diversity
Timepoint [3] 0 0
21 days
Secondary outcome [4] 0 0
Taxonomic richness
Timepoint [4] 0 0
21 days
Secondary outcome [5] 0 0
Relative abundance of core bacterial taxa
Timepoint [5] 0 0
21 days

Eligibility
Key inclusion criteria
* Able to give informed consent
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant or breastfeeding.
* Planning on becoming pregnant
* Diagnosed with iron deficiency and/or anaemia in the previous three months
* Taken antibiotics in the past three months
* Taken iron containing supplements in the past three months

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2022
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
SAHMRI - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven Taylor, PhD
Address 0 0
South Australian Health and Medical Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Outlined below

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Following final data analysis and primary publication
Available to whom?
Access to study data may be granted, upon review and approval of the Institutional Review Board, investigators, in accordance with South Australian Health and Medical Research Institute Women and Kids 'Guidelines and Agreement for the use of materials in an ancillary study associated with original clinical trials or cohort studies.
Available for what types of analyses?
How or where can data be obtained?


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/NCT05033483