A randomised controlled trial comparing daily (400 international units) and single bolus dosing (50,000 international units) of vitamin D in healthy breastfed infants of vitamin D deficient mothers.
Phase 2
Completed
- Conditions
- vitamin D deficiency in healthy term babies born the mothers who are vitamin D deficientMetabolic and Endocrine - Other metabolic disorders
- Registration Number
- ACTRN12613001234707
- Lead Sponsor
- Sunshine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
term, singleton babies
mothers with vitamin D levels < 50 at > 35 week
intention to breastfeed
Exclusion Criteria
intra-uterine growth restriction
pre-existing maternal diabetes, thyroid disorders
Neonates requiring significant resuscitation, CPR and intubation
maternal drug dependence
twin pregnancies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 25 OH vitamin D levels. This will be assessed by immunoassay on a Liason analyser.[at birth using cord blood.<br>at 6-8 days using blood collected from patients<br>at 3-4 months using blood collected from patients]
- Secondary Outcome Measures
Name Time Method Total Calcium and albumin levels as a measure of safety of vitamin D supplementation. These parameters will be measured by routine laboratory methods on a Beckman auto analyser.<br>[At birth<br>at 6-8 days<br>at 3-4 months];clinical parameters of vitamin D deficiency by assessment of growth parameters (head circumference, weight and length) and clinical signs of vitamin D deficiency such as craniotabes, widened anterior fontanelle, limb deformities, rachitic rosary.[At birth<br>at 6-8 days of age<br>at 3-4 months of age];measurement of compliance to vitamin D supplementation. This will be achieved by reconciling the remaining volumes of medication with expected volumes as recorded by the clinical trials pharmacy.[at 6-8 days<br>at 3-4 months on final review]