Study name	Prevention of vitamin A deficiency by supplementation alongside routine vaccinations: a randomised controlled trial in Ghana infants
Methods	Randomised controlled trial
Participants	Participant inclusion criteria
	1.Mothers normally resident in the study area 2.Informed consent obtained from the mother
	Participant exclusion criteria
	1.Mothers unable to give informed consent 2.Mothers considered to be at high risk of adverse outcome in puerperal period 3.Multiple deliveries 4.Severe adverse reaction to vitamin A supplementation
Interventions	1st Group:
	1.Mothers 200,000 IU vitamin A shortly after delivery 2.Infants: 25,000 IU vitamin A with each Diphtheria, Pertussis, Tetanus (DPT) vaccine 1, 2 and 3
	2nd Group:
	1.Mothers 200,000 IU vitamin A at infant's Bacillus Calmette‐Guerin (BCG) vaccine and another 200,000 IU vitamin A at infant's 1st DPT 2.Infants: 50,000 IU vitamin A with each DPT 1, 2 and 3
Outcomes	Primary outcome measure
	1.Serum retinol levels, assessed by carrying out mRDR testing of infants at 6 weeks, 6 and 9 months 2.Modified Retinol Dose Response (mRDR) tests 3.Incidence of side effects such as bulging of the anterior fontanel and vomiting 4.Incidence of severe morbidity
	Secondary outcome measures
	1.Breast milk retinol concentrations, assessed at 6 weeks, 6 and 9 months for an assessment of the impact of the different supplementation regimes 2.mRDR testing of infants at 9 months of age
Starting date	01/01/2004
Contact information	World Health Organization
	Geneva‐27
	CH‐1211
	Switzerland
Notes	No results are available