An interventional study of Vitamin D3 in Serum 25-hydroxyvitamin D Concentrations (25OHD), sponsored by University of Surrey. Completed at 1 site in United Kingdom. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-02.
Sponsored by University of Surrey · Not applicable, Interventional, and Prevention
It is known that low vitamin D status is a very common problem in the UK. It is also known that a lack of vitamin D availability has potentially serious health implications, especially with respect to bone and muscle function. Much research has recently taken place to establish the vitamin D requirements of key population groups (i.e. pregnant women, the elderly, ethnic minorities). However few data are available describing the vitamin D requirements for male and female adolescents. The period of adolescence is a key stage of growth and development - poor nutrition during this time can have detrimental health consequences for a lifetime.
No intervention studies have comprehensively investigated the vitamin D requirements of adolescents. The proposed ODIN Study will enable a better understanding of how adolescents respond to vitamin D supplementation and the most effective daily amount that will raise and maintain vitamin D status in adolescents during the winter-time. In addition, investigations into the mechanisms of action with respect to any differences observed across the doses of vitamin D and between the genders of the participants will also provide key information. Mechanisms of action will focus on genetic differences as well as differences in vitamin D metabolising enzymes.
The results obtained from this significant study will not only inform the European Food Standards Agency (EFSA) with respect to their imminent deliberations regarding vitamin D recommendations. The ODIN Study will also inform the UK Department of Health's Scientific Advisory Committee on Nutrition (SACN), the wider scientific community and be a critical resource for key stakeholders (i.e. food industry, government health agencies) to collaborate in determining future public health strategies, thus potentially positively impacting on the health of the population for years to come.
The investigators propose that the daily supplementation of 10µg/day (400 IU) and 20µg/day (800 IU) of vitamin D3 for five months will meet the vitamin D requirements of males and females aged 14-18 year and will be sufficient to maintain winter-time 25OHD levels above a range of thresholds between 30 and 50nmol/l.
University of Surrey is the lead sponsor of 90 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Participants will be given a daily supplement containing 10 micrograms (400 IU) vitamin D3 to take for 5 months.
Dietary Supplement: Vitamin D3
Participants will be given a daily supplement containing 20 micrograms (800 IU) vitamin D3 to take for 5 months.
Dietary Supplement: Vitamin D3
Participants will be given a placebo, similar in appearance to the vitamin D3 tablets, to take for 5 months.
Serum 25-hydroxyvitamin D concentrations
To investigate the vitamin D intakes needed to maintain serum 25-hydroxyvitamin D (25OHD) concentrations above the deficiency and insufficiency cut off thresholds (30nmol/l and 50nmol/l respectively) in male and female adolescents during the winter time.
Time frame: Baseline and after 5 months of supplementation
Identification of genetic polymorphisms for vitamin D
To investigate the mechanisms (genetic/enzymatic) underlying the differences observed in the preceding objective via genotyping the participants for polymorphisms related to vitamin D metabolism. Secondary analyses will include evaluation of variations in the response to supplementation by single SNP variations and by the genetic vitamin D risk score. To determine, through transcriptomic (global mRNA) analysis of leukocyte samples, genome-wide differences in gene expression, in the adolescents in response to the vitamin D3 supplementation.
Time frame: Baseline and after 5 months of supplementation
Family links in vitamin D levels and bone health
To determine the bone mineral density and vitamin D levels (in addition to the assessment of related blood markers and lifestyle factors) of the mothers of the adolescent participants, in order to establish possible familial links in the factors that affect vitamin D status and bone health.
Time frame: Baseline
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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University of Surrey