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
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Condition or disease | Intervention/treatment | Phase |
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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 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 |

Arm | Intervention/treatment |
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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).
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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.
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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%)
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Dietary Supplement: ready-to-use supplementary food |
- 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
- Maternal change in mid-upper arm circumference (MUAC) [ Time Frame: up to 40 weeks ]average change in mid-upper-arm circumference
- infant birth weight [ Time Frame: up to 40 weeks ]mean birth weights of infants born to mothers in the study
- infant birth length [ Time Frame: up to 40 weeks ]mean birth length of infants born to women in the study
- premature delivery [ Time Frame: up to 36 weeks ]proportion of infants born prematurely
- maternal weight gain [ Time Frame: up to 40 weeks ]
- maternal hemoglobin [ Time Frame: 8 weeks ]changes in average hemoglobin level
- pregnancy complications [ Time Frame: up to 40 weeks ]rate of pregnancy complications
- infant weight at 3 months [ Time Frame: 3 months ]
- infant length at 3 months [ Time Frame: 3 months ]
- infant survival at 3 months [ Time Frame: 3 months ]

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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 |
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

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
Malawi | |
Blantyre District | |
Blantyre, Malawi | |
Chikwawa District | |
Chikwawa, 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 | |
Principal Investigator: | Kenneth Maleta, MBBS PhD | University of Malawi | |
Principal Investigator: | Chrissie Thakwalakwa | University of Malawi |
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 |
Malnutrition Nutrition Disorders Folic Acid Hematinics Vitamin B Complex |
Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |