Interventions for Moderate Malnutrition in Pregnancy (Mamachiponde)

• ClinicalTrials.gov Identifier: NCT02120599
• Recruitment Status: Completed
• First Posted: April 23, 2014
• Last Update Posted: November 10, 2016
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy; Moderate Malnutrition	Dietary Supplement: ready-to-use supplementary food; Dietary Supplement: corn-soy blend; Dietary Supplement: iron; Dietary Supplement: folic acid; Dietary Supplement: UNIMMAP	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1867 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy
• Study Start Date: March 2014
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. maternal weight gain [ Time Frame: up to 40 weeks ]
2. maternal hemoglobin [ Time Frame: 8 weeks ]
   changes in average hemoglobin level
3. pregnancy complications [ Time Frame: up to 40 weeks ]
   rate of pregnancy complications
4. infant weight at 3 months [ Time Frame: 3 months ]
5. infant length at 3 months [ Time Frame: 3 months ]
6. infant survival at 3 months [ Time Frame: 3 months ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Malawi

Blantyre District

Blantyre, Malawi

Chikwawa District

Chikwawa, Malawi

Sponsors and Collaborators

Washington University School of Medicine

Investigators

• 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
• Principal Investigator: Kenneth Maleta, MBBS PhD; University of Malawi
• Principal Investigator: Chrissie Thakwalakwa; University of Malawi

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02120599
• Other Study ID Numbers: 201401112
• First Posted: April 23, 2014
• Last Update Posted: November 10, 2016
• Last Verified: November 2016

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders; Folic Acid; Hematinics; Vitamin B Complex; Vitamins; Micronutrients; Physiological Effects of Drugs