Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial)
Information source: Society for Applied Studies
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neonatal Vitamin A Supplementation
Intervention: Vitamin A (Drug)
Sponsored by: Society for Applied Studies
Official(s) and/or principal investigator(s):
Nita Bhandari, MD, PhD, Principal Investigator, Affiliation: Society for Applied Studies
Sunita Taneja, MD, PhD, Principal Investigator, Affiliation: Society for Applied Studies
Sarmila Mazumder, MD, PhD, Principal Investigator, Affiliation: Society for Applied Studies
The study is a large randomized controlled trial to assess the efficacy and safety of
neonatal vitamin A supplementation administered to neonates once orally either on the day of
birth or in the next 2 days in improving infant survival in the first 6 months of life.
Official title: Efficacy of Neonatal Vitamin A Supplementation in Improving Child Survival in Haryana, India: Generation of Evidence Necessary for Informing Global Policy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Risk of death
Risk of death
Risk of death
Risk of hospital admission
Bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned
Vitamin A status in a subgroup of newborns and caregivers in the intervention and placebo groups
The study is an individually randomized trial conducted in two districts in the state of
Community informants report births to the enrolment team. At enrolment, the team explains
the study to the family and in those willing, written consent is obtained from the parents
of the infant. The infant is given the dose of vitamin A/placebo and a form containing
baseline socioeconomic characteristics and information on feeding practices of the infant
and mother is filled.
After enrollment, each infant is visited by the enrollment team at hospital or home 1 day
and 3 days after supplementation to document any illnesses in the baby. Newborns with
illnesses are referred/escorted to the nearest health facility for management.
Enrolled infants are visited when aged 29 days, 3, 6 and 12 months to document vital status
and hospitalizations since the last visit. Information on feeding practices, immunization,
maternal intake of vitamin A rich foods and supplements, and intake of any supplement
containing vitamin A by the infant is recorded at these visits. Subgroup analyses includes
the effect of vitamin A supplementation in LBW and non LBW infants, male and female
infants, immunized and unimmunized infants, infants of families in the poorest and richest
quintiles and by vitamin A intake of mothers. For all deaths, verbal autopsy interviews are
Blood specimens are obtained in a subsample of infants at 2 weeks and 3 months of age and in
a subsample of mothers at 3 months of age.
Quality control activities include independent and supervised checks and are conducted for a
subsample by a separate team.
A DSMB has been constituted for the study. All deaths occurring within 72 hours of
supplementation will be reported to the SAS ERC and to the WHO Coordinating Unit.
At the recent DSMB meeting in February 2012, the DSMB recommended an increase in sample size
to 45,000 instead of the earlier estimate of 40,200 because of somewhat lower than expected
mortality rates. This increase in sample size is expected to preserve the specified power of
0. 85 and the corresponding level of precision anticipated at the design stage.
Similar trials are being funded by the World Health Organization (Geneva) in Ghana and
Minimum age: N/A.
Maximum age: 72 Hours.
- Consent to participate
- All births in the study area that are contacted by enrolment team within the eligible
- Unable to feed on offering feeds, as reported by the mother
- Mother does not intend to stay in the study area for at least 6 months
Locations and Contacts
Society for Applied Studies, New Delhi, Delhi 110016, India
NEOVITA Study Author Group, Bahl R, Bhandari N, Dube B, Edmond K, Fawzi W, Fontaine O, Kaur J, Kirkwood BR, Martines J, Masanja H, Mazumder S, Msham S, Newton S, Oleary M, Ruben J, Shannon C, Smith E, Taneja S, Yoshida S. Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial. Trials. 2012 Feb 23;13:22. doi: 10.1186/1745-6215-13-22.
Starting date: June 2010
Last updated: May 29, 2015