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

Inclusion Criteria4

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

Exclusion Criteria4

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

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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