Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/05/2014
Date assigned
08/05/2014
Last edited
23/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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.

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

Sponsor information

Organisation

University of Surrey (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

23/09/2016: Publication reference added.