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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Notify MeKey information
Conditions
Age range
14 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Blantyre District, Blantyre, Malawi
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
corn-soy blend
Dietary SupplementIron
Dietary SupplementFolic Acid
Dietary SupplementUNIMMAP
Dietary SupplementPrimary outcomes
-
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
Secondary outcomes
-
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
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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