Interventions for Moderate Malnutrition in Pregnancy (Mamachiponde)

The Washington University

Status: Completed

Conditions: Moderate Malnutrition; Pregnancy

Treatments: Dietary Supplement: folic acid; Dietary Supplement: ready-to-use supplementary food; Dietary Supplement: iron; Dietary Supplement: UNIMMAP; Dietary Supplement: corn-soy blend

Study type: Interventional

Funder types: Other

Identifiers

NCT02120599

201401112

Details and patient eligibility

About

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.

Enrollment: 1,867 patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant and consenting to study participation and HIV testing (if not already performed)
• mid-upper-arm circumference (MUAC) ≤ 23 cm
• planning to stay in the area and attend the clinic during pregnancy and for 3 months post partum

Exclusion criteria

• Pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
• Severe anemia (Hg <7.0 mg/dl)
• Severe malnutrition
• under 18 years of age
• over estimated 35 weeks of gestation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,867 participants in 3 patient groups

corn-soy-blend

Active Comparator group

Description:

This is the control group for the study, which will receive the Malawi standard of care. The treatment provided to women randomized to this arm of the study includes daily iron (60 mg) and folic acid (400 mcg) supplementation, along with 4 kg/2 weeks corn-soy blend (\~357 gm/d CSB).

Treatment:

Dietary Supplement: folic acid

Dietary Supplement: iron

Dietary Supplement: corn-soy blend

corn-soy-blend + multiple micronutrients

Experimental group

Description:

The treatment provided to women randomized to this arm of the study includes 200gm/d CSB along with a standard maternal multiple micronutrient tablet, which together provide a comparable amount of energy, protein and micronutrients to the ready-to-use supplemental food. The micronutrient supplement known as the United Nations Children's Emergency Fund (UNICEF) / World Health Organization (WHO) / United Nations University (UNU) international multiple micronutrient preparation (UNIMMAP) is widely available and has been used in many settings worldwide in pregnant women.

Treatment:

Dietary Supplement: corn-soy blend

Dietary Supplement: UNIMMAP

ready-to-use supplementary food

Experimental group

Description:

RUSF-P (ready-to-use supplementary food) provides 750 kcal/d, 20 g protein/d, and 200% of RDA/d for most micronutrients during pregnancy (except for vitamins A, B3, folic acid, minerals iodine, magnesium, and calcium which will remain near 100%)

Treatment:

Dietary Supplement: ready-to-use supplementary food