Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia

University of British Columbia547 enrolled

Overview

The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

547

Conditions

Maternal and Newborn Health

Interventions

Corn Soya Blend+DIETARY_SUPPLEMENT

A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * at least 18 years of age * in first trimester of pregnancy * plans to reside in the same village during the entire pregnancy Exclusion Criteria: * a minor * not in first trimester of pregnancy * plans to relocate during the pregnancy

Locations (1)

4 Health Centers

Kampong Chhnang, Cambodia

Outcomes

Primary Outcomes

Mean birth weight

Time frame: 9 months

Secondary Outcomes

Mean gestational weight gain

Time frame: 9 months

Mean maternal hemoglobin level

Time frame: 9 months

Mean birth length and head circumference

Time frame: 9 months

Data from ClinicalTrials.gov

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