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

Further Study Details: 

Primary Outcomes: Birth weight; 3-month infant mortality
Secondary Outcomes: Infant morbidity; Maternal morbidity; Maternal nutritional status; Weight gain during pregnancy; Infant growth
Expected Total Enrollment:  5000

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.

Ages Eligible for Study:  15 Years   -   45 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Study chairs or principal investigators

Parul Christian, DrPH,  Principal Investigator,  Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205   

Study ID Numbers:  H.22.98.09.02.C1
Record last reviewed:  April 2005
Last Updated:  June 30, 2005
Record first received:  June 21, 2005
ClinicalTrials.gov Identifier:  NCT00115271
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05