Interventions for Moderate Malnutrition in Pregnancy (Mamachiponde)

Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Moderate Malnutrition
• Intervention / Treatment: Dietary supplement: folic acid; Dietary supplement: iron; Dietary supplement: corn-soy blend; Dietary supplement: UNIMMAP; Dietary supplement: ready-to-use supplementary food

• Study Type: Interventional
• Enrollment (Actual): 1867
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • Blantyre District
  • Chikwawa, Malawi
    • Chikwawa District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Dietary supplement: folic acid; Dietary supplement: iron; Dietary supplement: corn-soy blend
Experimental: corn-soy-blend + multiple micronutrients; 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.	Dietary supplement: corn-soy blend; Dietary supplement: UNIMMAP
Experimental: 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%)	Dietary supplement: ready-to-use supplementary food

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Kenneth Maleta, MBBS PhD, University of Malawi; Principal Investigator: Chrissie Thakwalakwa, University of Malawi; Study Chair: Mark J Manary, MD, Washington University in St. Louis; University of Malawi; Study Director: Peggy C Papathakis, PhD, RD, California Polytechnic State University-San Luis Obispo

Publications and helpful links

General Publications

• Callaghan-Gillespie M, Schaffner AA, Garcia P, Fry J, Eckert R, Malek S, Trehan I, Thakwalakwa C, Maleta KM, Manary MJ, Papathakis PC. Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial. Am J Clin Nutr. 2017 Oct 1;106(4):1062-1069. doi: 10.3945/ajcn.117.157198.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 18, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): November 10, 2016
• Last Update Submitted That Met QC Criteria: November 9, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: 201401112