Interventions for Moderate Malnutrition in Pregnancy

NCT02120599 | Completed

• 1 other identifier: 201401112
• Study Type: interventional
• Target: 1,867
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy; Moderate Malnutrition

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• maternal weight gain

  up to 40 weeks

• maternal hemoglobin

  8 weeks

• pregnancy complications

  up to 40 weeks

• infant weight at 3 months

  3 months

• infant length at 3 months

  3 months

Study Arms (3)

corn-soy-blend

ACTIVE COMPARATOR

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: corn-soy blend; Dietary Supplement: iron; Dietary Supplement: folic acid

corn-soy-blend + multiple micronutrients

EXPERIMENTAL

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

ready-to-use supplementary food

EXPERIMENTAL

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

Interventions

ready-to-use supplementary food DIETARY_SUPPLEMENT

ready-to-use supplementary food

corn-soy blend DIETARY_SUPPLEMENT

corn-soy-blend; corn-soy-blend + multiple micronutrients

iron DIETARY_SUPPLEMENT

corn-soy-blend

folic acid DIETARY_SUPPLEMENT

corn-soy-blend

UNIMMAP DIETARY_SUPPLEMENT

corn-soy-blend + multiple micronutrients

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Blantyre District

Blantyre, Malawi

Location

Chikwawa District

Chikwawa, Malawi

Location

Related Publications (1)

• 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.

  PMID: 28793991 DERIVED

MeSH Terms

Interventions

Iron; Folic Acid

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mark J Manary, MD

  Washington University in St. Louis; University of Malawi

  STUDY CHAIR

• Peggy C Papathakis, PhD, RD

  California Polytechnic State University-San Luis Obispo

  STUDY DIRECTOR

• Kenneth Maleta, MBBS PhD

  University of Malawi

  PRINCIPAL INVESTIGATOR

• Chrissie Thakwalakwa

  University of Malawi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 23, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

MA (2)