Antenatal Micronutrient Supplementation and Birth Weight

This study is ongoing, but not recruiting participants.

First Received: June 21, 2005 Last Updated: September 6, 2006 History of Changes

Sponsor:	Johns Hopkins Bloomberg School of Public Health
Collaborators:	United States Agency for International Development (USAID) Bill and Melinda Gates Foundation Johns Hopkins University
Information provided by:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00115271

Purpose

The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal.

Condition	Intervention	Phase
Low Birth Weight Infant Mortality Pregnancy Nutritional Status	Drug: Nutritional supplements	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

Birth weight
3-month infant mortality

Secondary Outcome Measures:

Infant morbidity
Maternal morbidity
Maternal nutritional status
Weight gain during pregnancy
Infant growth

Estimated Enrollment:	5000
Study Start Date:	January 1999
Estimated Study Completion Date:	May 2001

Detailed Description:

Maternal micronutrient deficiencies are common in the developing world and may influence intrauterine growth and fetal and neonatal health and survival. Currently, policies for antenatal supplementation beyond iron-folic acid are not in place in these settings. And yet, the efficacy of such supplementation strategies has not been well established. Specifically, it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn health and survival compared to single or smaller combinations of micronutrients. Also, while birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality needs direct examination.

Comparisons: Pregnant women received daily folic acid, folic acid plus iron, folic acid plus iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with vitamin A compared to a control group that received only vitamin A.

Eligibility

Ages Eligible for Study:	15 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Married women of reproductive age identified as a new pregnancy using a urine test

Exclusion Criteria:

Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant <9 months of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115271

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

United States Agency for International Development (USAID)

Bill and Melinda Gates Foundation

Johns Hopkins University

Investigators

Principal Investigator:

Parul Christian, DrPH

Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205

More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lee AC, Darmstadt GL, Khatry SK, LeClerq SC, Shrestha SR, Christian P. Maternal-fetal disproportion and birth asphyxia in rural Sarlahi, Nepal. Arch Pediatr Adolesc Med. 2009 Jul;163(7):616-23.

Christian P, Darmstadt GL, Wu L, Khatry SK, Leclerq SC, Katz J, West KP Jr, Adhikari RK. The effect of maternal micronutrient supplementation on early neonatal morbidity in rural Nepal: a randomised, controlled, community trial. Arch Dis Child. 2008 Aug;93(8):660-4.

Study ID Numbers:	H.22.98.09.02.C1
Study First Received:	June 21, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00115271 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

Micronutrients
Supplementation
Pregnancy
Birth weight
Infant mortality

Additional relevant MeSH terms:

Body Weight
Birth Weight
Signs and Symptoms
Growth Substances

Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010