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
- Conditions
- Topic: Primary CareSubtopic: Not AssignedDisease: All DiseasesNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN40736890
- Lead Sponsor
- niversity of Surrey (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum 25-hydroxyvitamin D concentrations; Timepoint(s): End of study (20 weeks after supplementation has begun)
- Secondary Outcome Measures
Name Time Method ot provided at time of registration