Efficacy of newborn vitamin A supplementation in improving child survival in rural Ghana

None listed

The primary objective of our study is to determine if vitamin A supplementation (50,000 international units (IU)) given to neonates once orally either on the day of birth or in the next 2 days will reduce mortality in the first half of infancy by at least 15% as compared to placebo. Secondary objectives are to: (i) To determine if vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days will reduce mortality at 12 months by at least 15% as compared to placebo; (ii) determine the impact of the vitamin A supplementation on neonatal mortality (day 1-28); (iii) determine the impact of the vitamin A supplementation on the incidence of severe morbidity defined as hospitalisations due to any illness in the first 6 months of infancy; (iv) to document the potential adverse effects of vitamin A such as bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other condition that caused parents to be concerned, in the 3 days period following administration of the supplement and (v) to determine the vitamin A and C reactive protein (CRP) status of a subsample of infants at 2 weeks and 3 months of age in the vitamin A supplementation and placebo groups. This trial has been designed as an individually randomized, double-masked, placebo controlled efficacy trial. All infants randomized to the intervention group will receive 50,000 IU vitamin A either on the day of birth or in the next 2 days; the control group will receive a placebo. This study will be conducted over a 4 year period (Oct 2009 to Oct 2013) . The study area comprises 7 contiguous districts (Kintampo North, Kintampo South, Wenchi, Tain, Techiman, Nkoranza North and Nkoranza South) in the Brong Ahafo region of central rural Ghana, and covers 12,000 square kilometres. 70% of deliveries occur in health facilities in the study area. There will be four teams employed to work on this project: (i) 50 dosing supervisors who will be responsible for providing the vitamin A/placebo supplementation to the babies within 48 hours of birth and following up the babies day 1 and day 3 post supplementation (ii) 120 village based field workers who will be responsible for home visits and field surveillance of all women of reproductive age and monitoring outcomes in all study babies; (iii) a dedicated Information, Education, Communication (IEC) team who will be responsible for developing the birth notification system and liaising with the health facilities and communities included in the project; and (iv) a dedicated data management team who will be responsible for data entry and management of all questionnaires administered in this trial. Subgroup analyses will include the effect of vitamin A supplementation in LBW and non LBW infants, male and female infants, immunised and unimmunised infants, infants of families in the poorest and richest quintiles, and by vitamin A intake of mothers. For all deaths verbal autopsy interviews will be conducted.