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

ISRCTN	ISRCTN40736890
DOI	https://doi.org/10.1186/ISRCTN40736890
Secondary identifying numbers	16337

Submission date: 08/05/2014
Registration date: 08/05/2014
Last edited: 23/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Susan Lanham-New
Scientific

Faculty of Health and Medical Science
Guildford
GU2 7XH
United Kingdom

Email	s.lanhamnew@surrey.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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)
Study acronym	ODIN
Study objectives	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(s)	14/WM/0090; First MREC approval date 17/04/2014
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	19/05/2014
Completion date	24/10/2014

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Lower age limit	14 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 120; UK Sample Size: 120
Key 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)
Key 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.
Date of first enrolment	19/05/2014
Date of final enrolment	24/10/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Surrey

Guildford
GU2 7XH
United Kingdom

Sponsor information

University of Surrey (UK)
University/education

Faculty of Health and Medical Science
Guildford
GU2 7XH
England
United Kingdom

"ROR"	https://ror.org/00ks66431

Funders

Funder type

Government

Seventh Framework Programme (Grant Codes: 613977)
Government organisation / National government

Alternative name(s): EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2016		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

23/09/2016: Publication reference added.