The effects of vitamin D supplementation on bone density in vitamin D insufficient teenagers: randomised controlled trial

Phase 3

Recruiting

• Conditions: Bone development; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12608000299303
• Lead Sponsor: Menzies Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

1.healthy adolescents aged 15-17 years
2. mild to moderate vitamin D deficiency (serum 25-hydroxy vitamin D 12.5-50 nmol/L measured in July to October).
3. no known severe renal impairment, malabsorption, pregnancy, or lactation.
4. no clinical signs of rickets.

Exclusion Criteria

1. severe vitamin D deficiency (serum 25-hydroxy vitamin D less than 12.5 nmol/l)
2. vitamin D replete i.e. serum 25-hydroxy vitamin D greater than or equal to 50 nmol/L .
3. known severe renal impairment, malabsorption, pregnancy, or lactation.
4. clinical signs of rickets.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bone density (femoral neck bone mineral density, lumbar spine bone mineral density and total body bone mineral content) measured by Hologic Delphi bone densitometer[baseline, 12 months and 24 months]

Secondary Outcome Measures

Name	Time	Method
quantitative heel ultrasound measured at the heel by Sahara Clinical Bone Sonometer[baseline, then 6 monthly until 24 months]