Clinical trial NCT02120599: Interventions for Moderate Malnutrition in Pregnancy
Official title: Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Moderate Malnutrition
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 1867
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion recovered from moderate acute malnutrition (MAM)
timeFrame: up to 40 weeks
measure: Maternal change in mid-upper arm circumference (MUAC)
timeFrame: up to 40 weeks
measure: infant birth weight
timeFrame: up to 40 weeks
measure: infant birth length
timeFrame: up to 40 weeks
measure: premature delivery
timeFrame: up to 36 weeks
Secondary outcomes:
measure: maternal weight gain
timeFrame: up to 40 weeks
measure: maternal hemoglobin
timeFrame: 8 weeks
measure: pregnancy complications
timeFrame: up to 40 weeks
measure: infant weight at 3 months
timeFrame: 3 months
measure: infant length at 3 months
timeFrame: 3 months
measure: infant survival at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Blantyre District
city: Chikwawa
country: Malawi
facility: Chikwawa District
Study officials:
affiliation: Washington University in St. Louis; University of Malawi
name: Mark J Manary, MD
role: STUDY_CHAIR
affiliation: California Polytechnic State University-San Luis Obispo
name: Peggy C Papathakis, PhD, RD
role: STUDY_DIRECTOR
affiliation: University of Malawi
name: Kenneth Maleta, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malawi
name: Chrissie Thakwalakwa
role: PRINCIPAL_INVESTIGATOR
References:
citation: Callaghan-Gillespie M, Schaffner AA, Garcia P, Fry J, Eckert R, Malek S, Trehan I, Thakwalakwa C, Maleta KM, Manary MJ, Papathakis PC. Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial. Am J Clin Nutr. 2017 Oct 1;106(4):1062-1069. doi: 10.3945/ajcn.117.157198.