RecruitingPhase 3ACTRN12608000299303

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

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


Sponsor

Menzies Research Institute

Enrollment

670 participants

Start Date

Jun 21, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 15 YearssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether vitamin D supplements can improve bone development in teenagers who have mildly to moderately low vitamin D levels. Building strong bones in adolescence helps reduce the risk of osteoporosis and fractures later in life. This is a placebo-controlled trial, meaning some participants will receive vitamin D and others will receive a sugar pill. You may be eligible if: - You are between 15 and 17 years old - You are generally healthy - You have mild to moderate vitamin D deficiency (blood level between 12.5–50 nmol/L, measured in July–October) - You do not have severe kidney problems, malabsorption conditions, or signs of rickets - You are not pregnant or breastfeeding You may NOT be eligible if: - Your vitamin D level is severely low (below 12.5 nmol/L) - Your vitamin D level is already normal (50 nmol/L or above) - You have severe kidney disease, malabsorption, pregnancy, or lactation - You have clinical signs of rickets Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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


Locations(1)

Australia

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ACTRN12608000299303