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

• ClinicalTrials.gov Identifier: NCT01138449
• Recruitment Status: Completed
• First Posted: June 7, 2010
• Last Update Posted: June 1, 2015
• Sponsor: Society for Applied Studies
• Collaborator: World Health Organization
• Information provided by (Responsible Party): NBhandari, Society for Applied Studies

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Neonatal Vitamin A Supplementation	Drug: Vitamin A	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44984 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of Neonatal Vitamin A Supplementation in Improving Child Survival in Haryana, India: Generation of Evidence Necessary for Informing Global Policy
• Study Start Date: June 2010
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vitamin A; Vitamin A capsules have retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil	Drug: Vitamin A; 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
Placebo Comparator: Placebo; Placebo capsules contain minute amounts of vitamin E in soybean oil	Drug: Vitamin A; 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

Outcome Measures

Primary Outcome Measures :

1. Risk of death [ Time Frame: Period between receiving the intervention/placebo and six months of age ]
   To determine if vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days will reduce mortality in the first half of infancy as compared to placebo.

Secondary Outcome Measures :

1. Risk of death [ Time Frame: Period between receiving the intervention/placebo and 28 days of age ]
   To determine the efficacy of vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days in reducing mortality in the neonatal period (first month of life).
2. Risk of death [ Time Frame: Period between receiving the intervention/placebo and 12 months of age ]
   To determine the efficacy of vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days in reducing mortality at 12 months.
3. Risk of hospital admission [ Time Frame: Period between receiving the intervention/placebo and six months of age ]
   To determine the efficacy of the above intervention in reducing the incidence of severe morbidity defined as hospitalizations due to any illness in the first 6 months of infancy.
4. Bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned [ Time Frame: Three day period following supplementation ]
   To assess bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned, in the 3 day period following administration of the supplement
5. Vitamin A status in a subgroup of newborns and caregivers in the intervention and placebo groups [ Time Frame: Two weeks and three months of age ]
   To determine vitamin A status in a subsample of infants and caregivers in the intervention and placebo groups at 2 weeks and 3 months of age in the vitamin A supplementation and placebo groups

Eligibility Criteria

• Ages Eligible for Study: 2 Hours to 72 Hours (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

India

Society for Applied Studies

New Delhi, Delhi, India, 110016

Sponsors and Collaborators

Society for Applied Studies

World Health Organization

Investigators

• Principal Investigator: Nita Bhandari, MD, PhD; Society for Applied Studies
• Principal Investigator: Sunita Taneja, MD, PhD; Society for Applied Studies
• Principal Investigator: Sarmila Mazumder, MD, PhD; Society for Applied Studies

More Information

Publications of Results:

Mazumder S, Taneja S, Bhatia K, Yoshida S, Kaur J, Dube B, Toteja GS, Bahl R, Fontaine O, Martines J, Bhandari N; Neovita India Study Group. Efficacy of early neonatal supplementation with vitamin A to reduce mortality in infancy in Haryana, India (Neovita): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Apr 4;385(9975):1333-42. doi: 10.1016/S0140-6736(14)60891-6. Epub 2014 Dec 11.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Upadhyay RP, Martines JC, Taneja S, Mazumder S, Bahl R, Bhandari N, Dalpath S, Bhan MK. Risk of postneonatal mortality, hospitalisation and suboptimal breast feeding practices in low birthweight infants from rural Haryana, India: findings from a secondary data analysis. BMJ Open. 2018 Jun 22;8(6):e020384. doi: 10.1136/bmjopen-2017-020384.

• Responsible Party: NBhandari, Director, Society for Applied Studies
• ClinicalTrials.gov Identifier: NCT01138449
• Other Study ID Numbers: RPC356; UTRN 112336978-06032010834860 ( Registry Identifier: Clinical Trial Registry-India )
• First Posted: June 7, 2010
• Last Update Posted: June 1, 2015
• Last Verified: May 2015

Keywords provided by NBhandari, Society for Applied Studies:

Vitamin A; Neonatal mortality; Infant mortality

Additional relevant MeSH terms:

Vitamin A; Vitamins; Micronutrients; Physiological Effects of Drugs