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Completed

NCT Number: NCT02120599

Interventions for Moderate Malnutrition 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.

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Key information

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Blantyre District, Blantyre, Malawi

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ready-to-use supplementary food

Dietary Supplement

corn-soy blend

Dietary Supplement

Iron

Dietary Supplement

Folic Acid

Dietary Supplement

UNIMMAP

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: Mamachiponde

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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