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Interventions for Moderate Malnutrition in Pregnancy (Mamachiponde)

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120599


Locations
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Malawi
Blantyre District
Blantyre, Malawi
Chikwawa District
Chikwawa, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02120599    
Other Study ID Numbers: 201401112
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Folic Acid
Hematinics
Vitamin B Complex
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs