Antenatal Micronutrient Supplementation and Birth Weight

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

United States Agency for International Development (USAID)

Bill and Melinda Gates Foundation

Johns Hopkins University

Information provided by (Responsible Party):

Parul Christian, Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier:

NCT00115271

First received: June 21, 2005

Last updated: April 6, 2012

Last verified: April 2012

History of Changes

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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: Birth Weight 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 ClinicalTrials.gov Identifier (NCT Number):

Christian P, Morgan ME, Murray-Kolb L, LeClerq SC, Khatry SK, Schaefer B, Cole PM, Katz J, Tielsch JM. Preschool iron-folic acid and zinc supplementation in children exposed to iron-folic acid in utero confers no added cognitive benefit in early school-age. J Nutr. 2011 Nov;141(11):2042-8. Epub 2011 Sep 28.

Christian P, Murray-Kolb LE, Khatry SK, Katz J, Schaefer BA, Cole PM, Leclerq SC, Tielsch JM. Prenatal micronutrient supplementation and intellectual and motor function in early school-aged children in Nepal. JAMA. 2010 Dec 22;304(24):2716-23.

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.

Responsible Party:	Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00115271 History of Changes
Other Study ID Numbers:	H.22.98.09.02.C1
Study First Received:	June 21, 2005
Last Updated:	April 6, 2012
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:

Birth Weight
Body Weight
Signs and Symptoms
Micronutrients

Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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