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.
Phase 4
- Conditions
- Vitamin D deficiencyDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12609000874213
- Lead Sponsor
- The Children's Hospital at Westmead
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 140
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ormalisation of 25-hydroxyvitamin D levels to > 50 nmol/L by blood analysis.[At 12 weeks following randomisation.];Normalisation of alkaline phosphatase levels indicates restoration of bone mineral homeostasis by blood analysis.[At 12 weeks following randomisation.]
- Secondary Outcome Measures
Name Time Method Safety measure of urinary calcium: creatinine ratios.[At 4 and 12 weeks following randomisation.];Safety measure of other biochemical variables by blood analysis.[Following randomisation, blood analysis at 4 weeks to assess alkaline phosphatase concentrations and hypercalcaemia and at 12 weeks to assess for normalisation of mineral homeostasis.];Bone Age Assessment[At the baseline visit and only at 12 weeks to assess for resolution if rickets is present on x-ray.];Adherence as assessed by return medication.[At 4 weeks following randomisation for the high dose group and at 12 weeks following randomisation for the low dose group.]