Interventions for Moderate Malnutrition in Pregnancy

Pregnancy Clinical Trial

— Mamachiponde  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120599
• Other study ID #: 201401112
• Status: Completed
• Phase: N/A
• First received: April 18, 2014
• Last updated: November 9, 2016
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMalawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1867
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Moderate Malnutrition
• Pregnancy

Intervention

Dietary Supplement:
• ready-to-use supplementary food

• corn-soy blend

• iron

• folic acid

• UNIMMAP

Locations

Country	Name	City	State
Malawi	Blantyre District	Blantyre
Malawi	Chikwawa District	Chikwawa

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion recovered from moderate acute malnutrition (MAM)	proportion of women who reach mid-upper arm circumference (MUAC) > 23.5 cm for 2 consecutive visits	up to 40 weeks	No
Primary	Maternal change in mid-upper arm circumference (MUAC)	average change in mid-upper-arm circumference	up to 40 weeks	No
Primary	infant birth weight	mean birth weights of infants born to mothers in the study	up to 40 weeks	No
Primary	infant birth length	mean birth length of infants born to women in the study	up to 40 weeks	No
Primary	premature delivery	proportion of infants born prematurely	up to 36 weeks	No
Secondary	maternal weight gain		up to 40 weeks	No
Secondary	maternal hemoglobin	changes in average hemoglobin level	8 weeks	No
Secondary	pregnancy complications	rate of pregnancy complications	up to 40 weeks	No
Secondary	infant weight at 3 months		3 months	No
Secondary	infant length at 3 months		3 months	No
Secondary	infant survival at 3 months		3 months	No