Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania
(Neovita): a randomised, double-blind, placebo-controlled trial.
Author(s): Masanja H(1), Smith ER(2), Muhihi A(3), Briegleb C(2), Mshamu S(3), Ruben J(2),
Noor RA(4), Khudyakov P(2), Yoshida S(5), Martines J(5), Bahl R(5), Fawzi WW(2);
Neovita Tanzania Study Group.
Collaborators: Bakari M, Ballonzi I, Erasto E, Lubuga F, Gunaratna N, Shankar A,
Fontaine O.
Affiliation(s): Author information:
(1)Ifakara Health Institute, Dar es Salaam, Tanzania. Electronic address:
hmasanja@ihi.or.tz. (2)Harvard School of Public Health, Department of Global
Health and Population, Boston, MA, USA. (3)African Academy for Public Health, Dar
es Salaam, Tanzania. (4)Harvard School of Public Health, Department of Global
Health and Population, Boston, MA, USA; African Academy for Public Health, Dar es
Salaam, Tanzania. (5)Department of Maternal, Newborn, Child and Adolescent
Health, WHO, Geneva, Switzerland.
Publication date & source: 2015, Lancet. , 385(9975):1324-32
BACKGROUND: Supplementation of vitamin A in children aged 6-59 months improves
child survival and is implemented as global policy. Studies of the efficacy of
supplementation of infants in the neonatal period have inconsistent results. We
aimed to assess the efficacy of oral supplementation with vitamin A given to
infants in the first 3 days of life to reduce mortality between supplementation
and 180 days (6 months).
METHODS: We did an individually randomised, double-blind, placebo-controlled
trial of infants born in the Morogoro and Dar es Salaam regions of Tanzania.
Women were identified during antenatal clinic visits or in the labour wards of
public health facilities in Dar es Salaam. In Kilombero, Ulanga, and Kilosa
districts, women were seen at home as part of the health and demographic
surveillance system. Newborn infants were eligible for randomisation if they were
able to feed orally and if the family intended to stay in the study area for at
least 6 months. We randomly assigned infants to receive one dose of 50,000 IU of
vitamin A or placebo in the first 3 days after birth. Infants were randomly
assigned in blocks of 20, and investigators, participants' families, and data
analysis teams were masked to treatment assignment. We assessed infants on day 1
and day 3 after dosing, as well as at 1, 3, 6, and 12 months after birth. The
primary endpoint was mortality at 6 months, assessed by field interviews. The
primary analysis included only children who were not lost to follow-up. This
trial is registered with the Australian New Zealand Clinical Trials Registry
(ANZCTR), number ACTRN12610000636055.
FINDINGS: Between Aug 26, 2010, and March 3, 2013, 31,999 newborn babies were
randomly assigned to receive vitamin A (n=15,995) or placebo (n=16,004; 15,428
and 15,464 included in analysis of mortality at 6 months, respectively). We did
not find any evidence for a beneficial effect of vitamin A supplementation on
mortality in infants at 6 months (26 deaths per 1000 livebirths in vitamin A vs
24 deaths per 1000 livebirths in placebo group; risk ratio 1·10, 95% CI
0·95-1·26; p=0·193). There was no evidence of a differential effect for vitamin A
supplementation on mortality by sex; risk ratio for mortality at 6 months for
boys was 1·08 (0·90-1·29) and for girls was 1·12 (0·91-1·39). There was also no
evidence of adverse effects of supplementation within 3 days of dosing.
INTERPRETATION: Neonatal vitamin A supplementation did not result in any
immediate adverse events, but had no beneficial effect on survival in infants in
Tanzania. These results strengthen the evidence against a global policy
recommendation for neonatal vitamin A supplementation.
FUNDING: Bill & Melinda Gates Foundation to WHO.
|
