Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001172392
Ethics application status
Not required
Date submitted
7/08/2017
Date registered
10/08/2017
Date last updated
10/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Both childhood and long-term vitamin D status is associated with risk of type 2 diabetes mellitus in adulthood: a cohort study
Scientific title
Association between childhood and long-term vitamin D status and type 2 diabetes risk in adulthood
Secondary ID [1] 292594 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 304273 0
Impaired fasting glucose 304317 0
Type 2 diabetes mellitus 304318 0
Condition category
Condition code
Metabolic and Endocrine 303620 303620 0 0
Diabetes
Diet and Nutrition 303652 303652 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Childhood serum 25-hydroxyvitamin D (25OHD) levels were measured in 2010 using serum samples taken in 1980 and stored at -20°C. Serum 25OHD levels were remeasured using serum samples taken in 2001 (1094 measured by 2003 and the rest during 2011) and 2007 (measured in 2008). The Cardiovascular Risk in Young Finns Study is a multi-centre population-based follow-up study of cardiovascular risk factors in Finland(Raitakari OT, Juonala M, Rönnemaa T, Keltikangas-Jarvinen L, Rasanen L, Pietikainen M, Hutri-Kahonen N, Taittonen L, Jokinen E, Marniemi J, et al. Cohort profile: the cardiovascular risk in Young Finns Study. Int J Epidemiol 2008;37(6):1220-6.). In 1980 (baseline), 3,596 participants aged 3-18 years were randomly selected from the national register of the study areas. They were followed up in 2001, 2007 and 2011, when 2283, 2204 and 2060 (aged 34-50 years) participants were re-examined, respectively.
Intervention code [1] 298807 0
Not applicable
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302977 0
Primary outcome 1: Type 2 diabetes mellitus as assessed by meeting at least one of the followings: fasting plasma glucose (greater than or equal to 7 mmol/L or 126 mg/dl), diagnosis by a physician, HbA1c (greater than or equal to 6.5% or 48 mmol/mol at the 2011 follow-up), taking glucose-lowering medication at the 2007 or 2011 follow-up, or being recorded in the National Social Insurance Institution Drug Reimbursement Registry.
Timepoint [1] 302977 0
Time point: 2001, 2007 and 2011
Primary outcome [2] 303011 0
Primary outcome 2: impaired fasting glucose as assessed by fasting plasma glucose (greater than or equal to 5.6 but less than or equal to 6.9 mmol/L) at any of the follow-up visits (2001, 2007 and 2011).
Timepoint [2] 303011 0
Time point: 2001, 2007 and 2011
Secondary outcome [1] 337603 0
None.
Timepoint [1] 337603 0
Not applicable.

Eligibility
Key inclusion criteria
children and adolescents aged 3, 6, 9, 12, 15 and 18 years in all five Finnish university cities with medical schools and their rural surroundings.
Minimum age
3 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants who had Type 1 diabetes (n = 20) or were pregnant at each follow-up visits (n=91) were excluded from all analyses.
2. Participants who did not have complete risk factor data from baseline or adult T2DM data available from the 2001, 2007 or 2011 surveys.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Multinomial logistic regression was used to assess the association of both a) baseline 25-hydroxyvitamin D levels and, b) the mean of baseline and the latest follow-up 25-hydroxyvitamin D levels (as continuous variable and in quartiles) with incident type 2 diabetes and impaired fasting glucose in adult life.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/10/2016
Date of last participant enrolment
Anticipated
Actual
9/10/2016
Date of last data collection
Anticipated
Actual
23/01/2017
Sample size
Target
3596
Accrual to date
Final
2300
Recruitment outside Australia
Country [1] 9127 0
Finland
State/province [1] 9127 0
Helsinki, Turku, Tampere, Kuopio and Oulu

Funding & Sponsors
Funding source category [1] 297173 0
Government body
Name [1] 297173 0
National Health and Medical Research Council
Country [1] 297173 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
17 Liverpool Street, Hobart, Tasmania Australia
Country
Australia
Secondary sponsor category [1] 296191 0
None
Name [1] 296191 0
None
Address [1] 296191 0
NA.
Country [1] 296191 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 298341 0
Ethics committee address [1] 298341 0
Ethics committee country [1] 298341 0
Date submitted for ethics approval [1] 298341 0
Approval date [1] 298341 0
Ethics approval number [1] 298341 0

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

Contacts
Principal investigator
Name 76770 0
Prof Olli T. Raitakari
Address 76770 0
University of Turku
Research Centre of Applied and Preventive Cardiovascular Medicine
Kiinamyllynkatu 10
20520 Turku
FINLAND?
Country 76770 0
Finland
Phone 76770 0
+358 2 333 7556
Fax 76770 0
Email 76770 0
[email protected]
Contact person for public queries
Name 76771 0
Olli T. Raitakari
Address 76771 0
University of Turku
Research Centre of Applied and Preventive Cardiovascular Medicine
Kiinamyllynkatu 10
20520 Turku
FINLAND?
Country 76771 0
Finland
Phone 76771 0
+358 2 333 7556
Fax 76771 0
Email 76771 0
[email protected]
Contact person for scientific queries
Name 76772 0
Olli T. Raitakari
Address 76772 0
University of Turku
Research Centre of Applied and Preventive Cardiovascular Medicine
Kiinamyllynkatu 10
20520 Turku
FINLAND?
Country 76772 0
Finland
Phone 76772 0
+358 2 333 7556
Fax 76772 0
Email 76772 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.