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The effect of neonatal vitamin A supplementation on morbidity and mortality at 12 months: a randomized trial.

The effect of neonatal vitamin A supplementation on morbidity and mortality at 12 months: a randomized trial.
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Smith ER, Muhihi A, Mshamu S, Sudfeld CR, Noor RA, Spiegelman D, Shapiro RL, Masanja H, Fawzi W,


Smith ER, Muhihi A, Mshamu S, Sudfeld CR, Noor RA, Spiegelman D, Shapiro RL, Masanja H, Fawzi W, (click to view)

Smith ER, Muhihi A, Mshamu S, Sudfeld CR, Noor RA, Spiegelman D, Shapiro RL, Masanja H, Fawzi W,

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International journal of epidemiology 2016 Oct 27() pii

Abstract
BACKGROUND
Neonatal vitamin A supplementation (NVAS) is an intervention hypothesized to reduce infant morbidity and mortality. The objective of this study was to assess the efficacy of neonatal vitamin A supplementation in reducing infant morbidity and mortality and assess potential sources of heterogeneity of the effect of NVAS.

METHODS
We completed an individually randomized, double-blind, placebo-controlled trial in Tanzania. Infants were randomized within 3 days of birth to a single dose of vitamin A (50 000 IU) or placebo. We assessed infants at 1 and 3 days after supplementation, as well as 1, 3, 6 and 12 months after supplementation. We included all live births in the analysis and used relative risks (RR) and 95% confidence intervals (CI) to assess the risks of mortality and hospitalization by 12 months. We used general estimating equations to assess the incidence of morbidities during infancy.

RESULTS
A total of 31 999 infants were enrolled in the study between August 2010 and March 2013. At 12 months, vitamin A did not reduce all-cause infant mortality (RR 1.04; 95% CI 0.92-1.16), nor affect hospitalization (RR 1.09; 95% CI 0.97-1.22) or all-cause morbidity (RR 1.00; 95% CI 0.96-1.05). Postpartum maternal vitamin A supplementation modified the effect of neonatal vitamin A supplementation on mortality at 12 months (P-value, test for interaction = 0.04). Among infants born to women who received a mega-dose of vitamin A after delivery, NVAS appeared to increase the risk of death (RR 1.12; 95% CI 0.98-1.29), whereas the risk of death among infants born to women who did not receive a mega-dose was reduced (RR 0.86; 95% CI 0.70-1.06). We noted no modification of the effect of NVAS by infant gender, birthweight or maternal HIV status.

CONCLUSION
NVAS did not affect the risk of death or incidence of common childhood morbidities. However, this study sheds light on potential sources of heterogeneity of the effect of neonatal vitamin A supplementation which should be further examined in a pooled analysis of all NVAS trials.

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