Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial)

Society for Applied Studies

Status: Completed

Conditions: Neonatal Vitamin A Supplementation

Treatments: Drug: Vitamin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01138449

RPC356

UTRN 112336978-06032010834860 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44,984 patients

Sex: All

Ages: 2 to 72 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Consent to participate
• All births in the study area that are contacted by enrolment team within the eligible age window

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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44,984 participants in 2 patient groups, including a placebo group

Vitamin A

Experimental group

Description:

Vitamin A capsules have retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil

Treatment:

Drug: Vitamin A

Placebo

Placebo Comparator group

Description:

Placebo capsules contain minute amounts of vitamin E in soybean oil

Treatment:

Drug: Vitamin A