None listed
Conditions
Brief summary
Osteoporosis fractures are common, costly and cause significant death and disability. They may be reduced by improving the amount of bone laid down in childhood. Childhood vitamin D deficiency is common and is harmful for bone development. The use of vitamin D supplements in children to improve bone health needs further investigation. This study aims to determine what effect vitamin supplementation has on bone development in adolescents who have mild to moderate vitamin D deficiency. This will be tested through a placebo controlled randomised controlled trial of vitamin D supplementation in a sample of mild to moderately vitamin D deficient adolescents aged 15 to 17 years.
Interventions
150 000 international units (IU) (3 x 50 000 IU vitamin D3 tablets with 3 x identical inert placebo tablets) or 300 000 IU (6 x 50 000 IU vitamin D3 tablets) of vitamin D3 given orally every 6 months for 2 years
Sponsors
Menzies Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
15 Years to 17 Years
Healthy volunteers
Yes
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.
Outcome results
None listed