Vitamin A Supplementation in Newborns Study

• Status: Completed
• Trial end date: 2001-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was a randomized, community-based trial testing whether dosing newborn infants in the first few days after delivery with a large dose of vitamin A could reduce early infant morbidity, mortality and improve growth. Pregnant women in 2 districts of Tamil Nadu State in southern India were identified and recruited for participation. When the child was born, study staff were notified and traveled to the house to collect information and provide the vitamin A or placebo dose. Children were visited every two weeks until they were 6 months of age to collect information about vital status and morbidity. All children were discharged from the study at 6 months after growth was assessed and they received a 100,000 IU dose of vitamin A.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborator: Aravind Centre for Women and Children, Madurai, Tamil Nadu, India
• Treatments: Retinol palmitate; Vitamin A; Vitamins

Criteria

Inclusion Criteria:

• All live born children

Exclusion Criteria:

• Children who die prior to study staff visiting the home to enroll the child and deliver the assigned intervention.