Interventions for Moderate Malnutrition in Pregnancy

Summary

Malnutrition during pregnancy is more common in poor women in the developing world due to inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is more consequential than among other demographic groups with increased risk of maternal and infant mortality and the lifelong effects of fetal malnutrition. The benefits of treating moderate malnutrition during pregnancy remain largely undocumented. This study tests the hypothesis that providing either a fortified flour or fortified paste-based supplementary food designed to replete the nutrient deficits during pregnancy will result in improved maternal nutritional recovery rates and higher infant birth weights and lengths. This study is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately malnourished Malawian women who are pregnant. Subjects will receive one of 3 food rations: 1) a ready-to-use supplementary food formulated to deliver about 200% of the recommended daily allowance (RDA) of most micronutrients in pregnancy (RUSF-P), 2) corn soy blend with a multiple micronutrient tablet chosen to deliver about 200% of the RDA of most micronutrients (CSB-P) or 3), the standard of care which is a corn soy blend with supplementary iron and folic acid (CSB), delivering between 0-350% of the RDA. Subjects will receive the supplementary food until they recover from MAM. The outcome of the pregnancy and maternal nutritional status will be followed until 3 months after delivery.

Conditions

• Pregnancy
• Moderate Malnutrition

Interventions

DIETARY_SUPPLEMENT

ready-to-use supplementary food

DIETARY_SUPPLEMENT

corn-soy blend

DIETARY_SUPPLEMENT

iron

DIETARY_SUPPLEMENT

folic acid

DIETARY_SUPPLEMENT

UNIMMAP

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Mark J Manary, MD · Washington University in St. Louis; University of Malawi

• Peggy C Papathakis, PhD, RD · California Polytechnic State University-San Luis Obispo

• Kenneth Maleta, MBBS PhD · University of Malawi

• Chrissie Thakwalakwa · University of Malawi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• Malawi

Study Locations