Contact information
Type
Scientific
Primary contact
Prof Susan Lanham-New
ORCID ID
Contact details
Faculty of Health and Medical Science
Guildford
GU2 7XH
United Kingdom
-
s.lanhamnew@surrey.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16337
Study information
Scientific title
A dose-response, double-blind, randomised placebo-controlled trial to estimate the dietary requirement for vitamin D in male and female adolescents aged 14-18 years (The ODIN Study)
Acronym
ODIN
Study hypothesis
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 (at levels of 10µg and 20µg) 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 Healths 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.
Ethics approval
14/WM/0090; First MREC approval date 17/04/2014
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases
Intervention
Participants will be randomised to receive either 10mcg vitamin D, 20mcg vitamin D or a placebo
Follow Up Length: 5 month(s)
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Serum 25-hydroxyvitamin D concentrations; Timepoint(s): End of study (20 weeks after supplementation has begun)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/05/2014
Overall trial end date
24/10/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female
2. Aged between 14 and 18 years
3. In good health
4. Written informed consent from the adolescent (and parent if required)
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Participant exclusion criteria
1. Currently receiving treatment for medical conditions likely to affect vitamin D metabolism
2. Hypercalcaemia (>2.5mmol/l)
3. Regular use of sunbeds
4. Having a sun holiday one month prior to commencing the trial or plans for a sun holiday within the study period.
5. Use of vitamin supplements containing vitamin D if the prospective participant agrees to stop vitamin D supplementation to join the study, a washout period of 8 weeks prior to commencing the trial would be acceptable.
6. Excessive consumption of alcohol (>14 units per week for females, >21 units per week for males)
7. Smoking >10 cigarettes per day
8. Those following a weight-reducing diet or under dietary restriction (except vegetarianism)
9. Known intolerance/allergy to the constituent ingredients of the daily supplement
10. Clinically significant haematological abnormalities other than mild anaemia (Hb<12.0g/dl)
11. Active malignancy
12. Pregnant or planning a pregnancy during the study period.
Recruitment start date
19/05/2014
Recruitment end date
24/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Surrey
Guildford
GU2 7XH
United Kingdom
Funders
Funder type
Government
Funder name
Seventh Framework Programme (Grant Codes: 613977)
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Belgium
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27655438