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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

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40736890
Enrollment
120
Registered
2014-05-08
Start date
2014-05-19
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Primary Care

Interventions

Participants will be randomised to receive either 10mcg vitamin D, 20mcg vitamin D or a placebo Follow Up Length: 5 month(s)

Sponsors

University of Surrey (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Serum 25-hydroxyvitamin D concentrations; Timepoint(s): End of study (20 weeks after supplementation has begun)

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026