Vitamin D for correcting deficiency in adolescents: a generalpractice-based randomised controlled trial
- Conditions
- Vitamin D deficiencyMusculoskeletal - Osteoporosis
- Registration Number
- ACTRN12613000700730
- Lead Sponsor
- Menzies Research Institute Tasmania, University of Tasmania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
Healthy adolescents aged 15-17 years.
Mild to moderate vitamin D deficiency (serum 25-OHD 12.5-50 nmol/L).
No known severe renal impairment, malabsorption, pregnancy, or lactation.
No clinical signs of rickets.
No reason known to GP to prevent participation or which makes making contact with the young person inappropriate (there may be cases where for reasons of patient confidentiality the GP will not wish a letter to be sent to a young person’s parents for example).
Normal vitamin D levels (serum 25-OHD > 50 nmol/L).
Severe vitamin D deficiency (serum 25-OHD < 12.5 nmol/L). These patients will be referred to their GP for assessment and consideration of treatment. We will send a copy of these results together with a letter outlining appropriate treatment advice to the GP.
Known severe renal impairment, malabsorption, pregnancy, or lactation.
Clinical signs of rickets.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correction of vitamin D deficiency which will be assessed by blood test measuring serum 25-hydroxyvitamin D [3, 6, and 12 months from commencement of treatment]
- Secondary Outcome Measures
Name Time Method Feasibility of using general practice as the setting through which vitamin D deficient adolescents can be identified and treated. This will be assessed by assessing how long it takes to recruit 33 adolescents and keeping track of the number of adolescents contacted, screened and then enrolled in the study. <br><br><br>[Recruitment and screening];Obtaining pilot bone density outcome data by measuring bone mineral density (BMD) at the total hip, lumbar spine and femoral neck determined using dual-energy x-ray absorptiometry. [12 months from commencement of treatment]