Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh

Vitamin A Deficiency Clinical Trial

Official title:

A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128557
• Other study ID #: H.22.03.01.09.A2
• Status: Completed
• Phase: Phase 3
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.

Description:

This is a randomized, double-masked, placebo-controlled, community trial of newborn vitamin A supplementation on mortality in the first six months of life. The trial is being implemented in 596 sectors (i.e. villages and/or smaller groupings), in two thanas comprising a population of ~580,000 in rural northern Bangladesh (Gaibandha/Rangpur area) and is nested within the JiVitA-1 maternal supplementation study. Women residing in the study area are already under 5-weekly pregnancy surveillance conducted by village-based field staff as part of the maternal supplementation trial. During their third trimester of pregnancy, women are visited by a study supervisor who explains the purpose and procedures of the study. After obtaining informed consent, women are interviewed for possible risk factors in the third trimester of pregnancy, including a 30-day history of morbidity, a 7-day dietary and alcohol intake and tobacco use questionnaire, a 7-day household chores questionnaire, and maternal anthropometry (mid upper arm circumference measurement). Upon birth, household members contact the village-based field staff who immediately administers the vitamin A or placebo to the infant, according to sector assignment. After supplementation, newborns are measured for weight, length and mid-upper arm, head and chest circumference, and then followed weekly for vital status for three months, and again at six months of age. A child death initiates the process of death verification and cause of death determination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15937
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Minute to 30 Days

Eligibility

Inclusion Criteria: Infants born to women enrolled in a maternal supplementation trial, alive and less than 30 days of age during a newborn dosing visit Exclusion Criteria: Infants who died before the dose could be administered or infants older than 30 days at the time of dosing

Related Conditions & MeSH terms

• Infant Death
• Night Blindness
• Vitamin A Deficiency

Intervention

Dietary Supplement:
• vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)
Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo

Locations

Country	Name	City	State
Bangladesh	JiVitA Bangladesh Project	Rangpur	Rajshahi Division

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Access Business Group, Bill and Melinda Gates Foundation, Canadian International Development Agency, Johns Hopkins University, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-week infant mortality rate

External Links

•   Micronutrient research at the Center for Human Nutrition at Johns Hopkins Bloomberg School of Public Health)