This is a randomised study to assess the safety and efficacy of a high dose vitamin D supplement compared to the standard vitamin D therapy in children.

A study to assess the safety and efficacy of stoss therapy (high dose vitamin D supplement) compared to standard daily therapy in children diagnosed with simple vitamin D deficiency.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000874213

Enrollment

140

Registered

2009-10-07

Start date

2009-11-01

Completion date

Unknown

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

This study is a randomised study that will investigate the safety and effacy of stoss therapy (high dose weekly vitamin D supplementation for 4 weeks) compared to daily vitamin D for 3 months. The hypothesis is that stoss vitamin D therapy is a safe and effective treatment for vitamin D deficency. If proven safe and effective, stoss therapy would have significant advantages where therapy is shortened, thus improving compliance and ultimate recovery from Vitamin D deficiency.

Interventions

An oral intervention of 100,000 IU cholecalciferol weekly for 4 weeks with calcium supplementation 500mg daily for 4 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

2 Years to 16 Years

Healthy volunteers

Inclusion criteria

Diagnosis of simple Vitamin D deficiency, <50 nmol/L. Be under the care of Endocrinologist and / or Refugee Clinic paediatrician

Exclusion criteria

Pre-existing medical condition predisposing to Vitamin D deficiency e.g malabsorption. Bone active medication e.g bisphosphonates. anticonvulsants. No metabolic cause for rickets

Outcome results