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.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2013
INTERVENTION: arm 1: 400IU vitamin D orally ‐ Pentavite (Bayer Health) given daily for 4 months from birth arm 2: 50,000 vitamin D orally ‐ Given as pharmacy formulated Cholecalciferol as a single dose at birth only. Patients will be followed up at 6‐8 days of age and 3‐4 months of age for biochemical markers of vitamin D deficiency (vitamin D and calcium levels) and reviewed for compliance, growth, side effects and signs of vitamin d deficiency CONDITION: vitamin D deficiency in healthy term babies born the mothers who are vitamin D deficient PRIMARY OUTCOME: 25 OH vitamin D levels. This will be assessed by immunoassay on a Liason analyser. SECONDARY OUTCOME: 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. 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. 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. ; INCLUSION CRITERIA: term, singleton babies mothers with vitamin D levels < 50 at > 35 week intention to breastfeed
Epistemonikos ID: 5702343089660ee7146cf9562cee323fd562752b
First added on: Aug 22, 2024