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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Infant Mortality; Vitamin A Deficiency	Drug: vitamin A supplementation (50,000 IU)	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional
Enrollment :	25000 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double
Primary Purpose:	Prevention
Official Title:	A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
Study Start Date :	January 2004
Actual Study Completion Date :	December 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 24-week infant mortality rate

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 30 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Bangladesh
JiVitA Bangladesh Project
Rangpur, Rajshahi Division, Bangladesh

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

United States Agency for International Development (USAID)

Johns Hopkins University

Bill and Melinda Gates Foundation

Canadian International Development Agency

Access Business Group

Investigators

Principal Investigator:	Rolf DW Klemm, Dr PH	Johns Hopkins University
Study Director:	Keith P West, Jr., Dr. P.H.	Johns Hopkins Bloomberg School of Public Health
Study Director:	Parul Christian, Dr. P.H.	Johns Hopkins Bloomberg School of Public Health
Study Director:	Mahbubar Rashid, MBBS, MSc, MBA	JiVitA Bangladesh Project
Study Director:	Alain B. Labrique, MSc	Johns Hopkins Bloomberg School of Public Health
Study Director:	Alfred Sommer, M.D.	Johns Hopkins Bloomberg School of Public Health

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ali H, Hamadani J, Mehra S, Tofail F, Hasan MI, Shaikh S, Shamim AA, Wu LS, West KP Jr, Christian P. Effect of maternal antenatal and newborn supplementation with vitamin A on cognitive development of school-aged children in rural Bangladesh: a follow-up of a placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Jul;106(1):77-87. doi: 10.3945/ajcn.116.134478. Epub 2017 May 10.

Coles CL, Labrique A, Saha SK, Ali H, Al-Emran H, Rashid M, Christian P, West KP Jr, Klemm R. Newborn vitamin A supplementation does not affect nasopharyngeal carriage of Streptococcus pneumoniae in Bangladeshi infants at age 3 months. J Nutr. 2011 Oct;141(10):1907-11. doi: 10.3945/jn.111.141622. Epub 2011 Aug 10.

ClinicalTrials.gov Identifier:	NCT00128557 History of Changes
Other Study ID Numbers:	H.22.03.01.09.A2
First Posted:	August 10, 2005
Last Update Posted:	April 10, 2007
Last Verified:	April 2007

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

Vitamin A; Newborn health; Infant Mortality	Supplementation; Micronutrients; Bangladesh

Additional relevant MeSH terms:

Vitamin A Deficiency; Vitamin A; Retinol palmitate; Night Blindness; Infant Death; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vision Disorders; Eye Diseases	Death; Pathologic Processes; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Anticarcinogenic Agents; Antineoplastic Agents