Interventions for Moderate Malnutrition in Pregnancy

Not Applicable

Completed

• Conditions: Moderate Malnutrition; Pregnancy
• Interventions: Dietary Supplement: corn-soy blend; Dietary Supplement: ready-to-use supplementary food; Dietary Supplement: UNIMMAP; Dietary Supplement: iron; Dietary Supplement: folic acid

• Registration Number: NCT02120599
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-23
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1867

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corn-soy-blend + multiple micronutrients	corn-soy blend	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.
ready-to-use supplementary food	ready-to-use supplementary food	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%)
corn-soy-blend + multiple micronutrients	UNIMMAP	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.
corn-soy-blend	corn-soy blend	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).
corn-soy-blend	folic acid	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).
corn-soy-blend	iron	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).

Primary Outcome Measures

Name	Time	Method
Maternal change in mid-upper arm circumference (MUAC)	up to 40 weeks	average change in mid-upper-arm circumference
infant birth weight	up to 40 weeks	mean birth weights of infants born to mothers in the study
Proportion recovered from moderate acute malnutrition (MAM)	up to 40 weeks	proportion of women who reach mid-upper arm circumference (MUAC) \> 23.5 cm for 2 consecutive visits
premature delivery	up to 36 weeks	proportion of infants born prematurely
infant birth length	up to 40 weeks	mean birth length of infants born to women in the study

Secondary Outcome Measures

Name	Time	Method
pregnancy complications	up to 40 weeks	rate of pregnancy complications
maternal weight gain	up to 40 weeks
infant length at 3 months	3 months
maternal hemoglobin	8 weeks	changes in average hemoglobin level
infant survival at 3 months	3 months
infant weight at 3 months	3 months

Trial Locations

Locations (2)

Blantyre District; 🇲🇼 Blantyre, Malawi

Chikwawa District; 🇲🇼 Chikwawa, Malawi