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

NCT01138449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44984

Last updated 2015-06-01

No results posted yet for this study

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.

Conditions

  • Neonatal Vitamin A Supplementation

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Nita Bhandari, MD, PhD · Society for Applied Studies

  • Sunita Taneja, MD, PhD · Society for Applied Studies

  • Sarmila Mazumder, MD, PhD · Society for Applied Studies

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01138449 on ClinicalTrials.gov