Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial)
Condition: Neonatal Vitamin A Supplementation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The study is an individually randomized trial conducted in two districts in the state of
      Haryana.

      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 conducted.

      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
      Tanzania.
    

Intervention name(s): Vitamin A
Intervention type(s): Drug
Intervention description(s): Retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil, orally as a single dose to neonates on the day of birth or in the next 2 days of birth keeping a minimum period of 2 hours between the birth and the dosing
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin A; Neonatal mortality; Infant mortality