Dietary Requirement for Vitamin D in Adolescents Aged 14-18 Years

March 1, 2016 updated by: University of Surrey

A Dose-response, Double-blind Randomised Placebo-controlled Trial to Estimate the Dietary Requirement for Vitamin D in Caucasian Male and Female Adolescents Aged 14-18 Years (The ODIN Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XH
        • University of Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • Aged between 14 and 18 years
  • Caucasian ethnicity
  • In good health
  • Written informed consent from the adolescent (and parent if required)

Exclusion Criteria:

  • Currently receiving treatment for medical conditions likely to affect vitamin D metabolism
  • Hypercalcaemia (>2.5mmol/l)
  • Regular use of sun-beds
  • Having a sun holiday one month prior to commencing the trial or plans for a sun holiday within the study period.
  • Use of vitamin supplements containing vitamin D - if the prospective participant agrees to stop vitamin D supplementation to join the study, a wash-out period of 8 weeks prior to commencing the trial would be acceptable.
  • Excessive consumption of alcohol (>14 units per week for females, >21 units per week for males)
  • Smoking >10 cigarettes per day
  • Those following a weight-reducing diet or under dietary restriction (except vegetarianism)
  • Known intolerance/allergy to the constituent ingredients of the daily supplement
  • Clinically significant haematological abnormalities other than mild anaemia (Hb<12.0g/dl)
  • Active malignancy
  • Pregnant or planning a pregnancy during the study period.
  • Breast-feeding mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 micrograms (400 IU) vitamin D3
Participants will be given a daily supplement containing 10 micrograms (400 IU) vitamin D3 to take for 5 months.
Dietary supplement: Vitamin D3
Experimental: 20 micrograms (800 IU) 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
No Intervention: Placebo
Participants will be given a placebo, similar in appearance to the vitamin D3 tablets, to take for 5 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum 25-hydroxyvitamin D concentrations
Time Frame: Baseline and after 5 months of supplementation
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.
Baseline and after 5 months of supplementation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of genetic polymorphisms for vitamin D
Time Frame: Baseline and after 5 months of supplementation
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.
Baseline and after 5 months of supplementation
Family links in vitamin D levels and bone health
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Investigators

  • Principal Investigator: Susan Lanham-New, Professor, University of Surrey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ODIN/1213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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