Efficacy of newborn vitamin A supplementation versus placebo in improving child survival in Tanzania

Not Applicable

Completed

• Conditions: Mortality in the first year of infancy; Mortality in the neonatal period (from enrollment until day 28); Incidence of severe morbidity defined as hospitalizations due to any illness in the first year of infancy; Adverse effects of vitamin A in the 3 days period following administration of the supplement; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12610000636055
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32000

Inclusion Criteria

1.) All births in the study area that are between two hours and two days of age, whose caretakers confirm of intention to remain in the study areas for a minimum of six months thereafter, will be eligible for inclusion in this study.
2.) Both singleton and multiple births are eligible for inclusion in this study and each infant will be provided with their own unique study identification number.
3.) Infants will be included even if they were not identified during pregnancy surveillance.

Exclusion Criteria

1.) Unable to feed if offered feeds as reported by the mother
2.) Mother does not intend to stay in the study area for at least 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of death, assessed by parent interview[Period between receiving the intervention/placebo and 1 year]

Secondary Outcome Measures

Name	Time	Method
Risk of death, assessed by parent interview[Period between receiving the intervention/placebo and 28 days of age];Risk of hospital admission, assessed by parent interview[Period between receiving the intervention/placebo and 1 year.];Proportion of newborns with adverse events such as bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that cause parents to be concerned, assessed by parent interview and direct examination of the infant[Three day period following supplementation];Vitamin A status of newborns in the intervention and placebo groups in a small randomly selected subgroup, assessed by blood analysis.[Two weeks and three months of age]