1 Open - Odense Patient data Explorative Network, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU2 Sundhedsvaner/Livsstil, National Institute of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU3 Institut for Klinisk Medicin4 unknown5 SUND ph.d. skole6 Sundhedsvaner/Livsstil, National Institute of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU7 Open - Odense Patient data Explorative Network, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU
two by two factorial randomised controlled trial
BACKGROUND: Vitamin A supplementation (VAS) may amplify the effect of vaccines. We therefore investigated if neonatal VAS given with and without Bacille Calmette-Guerin (BCG) vaccine to low-birth-weight (LBW) neonates had an effect on growth in the first year of life. We hypothesised that VAS would be particularly beneficial when provided with BCG. METHODS: We conducted a randomised two-by-two factorial trial in Guinea-Bissau; 1,717 LBW neonates were randomly allocated to VAS or placebo at birth as well as early or the usual postponed BCG vaccination. Anthropometric measurements were obtained at 2, 6, and 12 months after inclusion. RESULTS: Overall there was no effect of neonatal VAS on growth in the first year of life. By 2 months, VAS tended to have a beneficial effect on weight and head circumference when given with BCG but not when given without BCG (interaction: weight-for-age p = 0.07 and head circumference-for-age: p = 0.06). By 6 months, there was a beneficial effect of VAS on head circumference and weight among children who had not received DTP vaccine 2 months after inclusion (weight: 0.18 (0.00; 0.36) and head circumference 0.27 (0.06; 0.48)), but no beneficial effect among those who had received DTP. CONCLUSION: The results support other trials indicating that neonatal VAS does not have consistent effects on childhood growth and if anything the effects seem to be temporary. They also show that the effect may differ by vaccination status, being beneficial when given with BCG at birth and when DTP is delayed.Trial registration: www.ClinicalTrials.gov (NCT00168610).
B M C Pediatrics, 2013, Vol 13, Issue 1
neonatal vitamin A, low-birth-weight infants, Guinea-Bissau, randomised, trial