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Vitamin D for correcting deficiency in adolescents: a general practice-based randomised controlled trial

Vitamin D deficient adolescents randomised to 50000 international units (IU) of vitamin D3 given orally monthly or 150000 IU of vitamin D3 given orally 3-monthly or placebo given monthly and 3-monthly, assessed by correcting vitamin D deficiency, feasibility of recruiting adolescents using general practice, and obtaining pilot bone density outcome data.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000700730
Acronym
GP VitD
Enrollment
28
Registered
2013-06-26
Start date
2013-10-14
Completion date
2015-04-08
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Adolescents are at particular risk of vitamin D deficiency and are also a group who may not take medications regularly. The optimal dosage regimen for adolescents to help them take vitamin D regularly enough to correct deficiency is not known. Therefore the main aim of this study is to test two different vitamin D dosage regimens to see if they can both correct vitamin D deficiency in adolescents. The study will also show whether vitamin D deficient adolescents can be successfully identified through general practice and provide preliminary pilot data on whether correcting vitamin D deficiency results in significant improvements in bone density.

Interventions

50000 IU vitamin D3 orally monthly or 150000 IU (3 x 50 000 IU tablets) orally 3-monthly for 12 months

Sponsors

Menzies Research Institute Tasmania, University of Tasmania
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
15 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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).

Exclusion criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026