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

Information source: Society for Applied Studies
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Vitamin A Supplementation

Intervention: Vitamin A (Drug)

Phase: N/A

Status: Recruiting

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

Overall contact:
Nita Bhandari, MD, PhD, Phone: 00 91 11 46043751-55, Ext: 201, Email: CHRD@sas.org.in

Summary

The study will be 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.

Clinical Details

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

Secondary outcome:

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

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

Community informants will report births to the enrollment team. At enrollment, the team will explain the study to the family and in those willing, written consent will be obtained from the parents of the infant. The infant will be given the dose of vitamin A/placebo and a form containing baseline socioeconomic characteristics and information on feeding practices of the infant and mother will be filled.

After enrollment, each infant will be 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 will be referred/escorted to the nearest health facility for management.

Enrolled infants will be 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 will also be recorded at these visits. Subgroup analyses will include 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 will be conducted.

Blood specimens will be 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 will be 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 IRB and to the WHO Coordinating Unit.

Similar trials are being funded by the World Health Organization (Geneva) in Ghana and Tanzania.

Eligibility

Minimum age: N/A. Maximum age: 72 Hours. Gender(s): Both.

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

Locations and Contacts

Nita Bhandari, MD, PhD, Phone: 00 91 11 46043751-55, Ext: 201, Email: CHRD@sas.org.in

Society for Applied Studies, New Delhi, Delhi 110016, India; Recruiting
Nita Bhandari, MD, PhD, Phone: 00 91 11 46043751-55, Ext: 201, Email: CHRD@sas.org.in
Sunita Taneja, MD, PhD, Phone: 00 91 11 46043751-55, Ext: 301, Email: CHRD@sas.org.in
Nita Bhandari, MD, PhD, Principal Investigator
Sunita Taneja, MD, PhD, Principal Investigator
Sarmila Mazumder, MD, PhD, Principal Investigator
Additional Information

Starting date: June 2010
Last updated: July 19, 2011

Page last updated: December 08, 2011

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