The effect of daily versus depot vitamin D3 supplementation on vitamin D deficiency in Aboriginal children and adolescents in metropolitan and rural Western Australia

• Conditions: Vitamin D deficiency; Metabolic and Endocrine - Other metabolic disorders; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12609000269235
• Lead Sponsor: Jason K Tan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Aboriginal children aged 0-16 years old
2. Attending hospital or attending outpatient clinics
3. Require a blood test as part of their clinical management
4. Have a low vitamin D level (<78nmol/L)

Exclusion Criteria

1. Children already diagnosed with low vitamin D levels and are receiving vitamin D supplementation
2. Children with immune deficiency
3. Children with chronic liver disease
4. Children with chronic renal disease
5. Children with cardiac disease
7. Children taking anticonvulsant medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment efficacy - rise in vitamin D level of 25nmol/L over 6 weeks. The 25(OH)D3 level will be measured on the DiaSorin Liaison. A rise of 25nmol/L over 6 weeks has been chosen as a marker of efficacy as previous studies suggests that adequate treatment with vitamin D supplements will lead to a minimum average rise of 25nmol/L. This increase also correlates with moving to a higher strata group in our predetermined strata of vitamin D levels (<25nmol/L is deficient; 25-50nmol/L is moderate insufficiency; 50-78nmol/L is mildly insufficient)[6 weeks after commencement of treatment]

Secondary Outcome Measures

Name	Time	Method
Difference between mean rise in vitamin D level in the daily and depot groups. The 25(OH)D3 levels will be measured on the DiaSorin Liaison.[6 weeks, 6 months after the commencement of treatment];Proportion of individuals with a normal vitamin D level at 6 weeks and 6 months. The 25(OH)D3 levels will be measured on the DiaSorin Liaison.[6 weeks, 6 months after commencement of treatment]