Combination of bolus dose vitamin D with routine vaccination in infants: a randomised trial

Introduction: The present study was designed to compare two methods of vitamin D supplementation in infants: every two months as a routine vaccination versus a daily dose. Methods: A randomised clinical trial was performed on 120 healthy breastfed infants between January and September 2007 in Yazd, Iran. The infants were randomly divided into three groups with different doses of vitamin D-3 supplementation: 200 IU daily, 400 IU daily and a bolus of 50,000 IU every two months. A blood sample was taken and evaluated for 25-hydroxy vitamin D and calcium levels when the infants were six months old. The data was reported as the mean and standard deviation. Results: No significant differences were observed between the serum level of 25-hydroxy vitamin D in the groups administered with 200 IU and 400 IU vitamin D daily. However, the serum level of 25-hydroxy vitamin D reached significance in the third group (p is less than 0.001). All the blood calcium measured was below 11 mg/dl in the bolus group. A few complications such as diarrhoea and agitation, all of which were self-limited, were seen in the bolus group. No other significant side effects were reported in the other groups. Conclusion: This study demonstrates that a bolus of 50,000 IU of vitamin D every two months with a routine child vaccination program provides the ideal serum level of vitamin D. This method produces no serious side effects and offers a highly convenient way to supply vitamin D, especially among non-compliant parents.