Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)
Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes
1 other identifier
interventional
1,489
1 country
1
Brief Summary
Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Feb 2017
Typical duration for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2017
CompletedFirst Submitted
Initial submission to the registry
March 5, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2020
CompletedJanuary 7, 2021
January 1, 2021
2.6 years
March 5, 2017
January 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Infant birth length
mean birth length of infants born to mothers in the study
up to 40 weeks
Secondary Outcomes (8)
Maternal weight gain
up to 40 weeks
Proportion recovered from maternal malnutrition
up to 40 weeks
Premature delivery
up to 36 weeks
Newborn head circumference
up to 40 weeks
Infant birth weight
up to 40 weeks
- +3 more secondary outcomes
Study Arms (2)
Ready-to-use supplementary food + anti-infective bundle
EXPERIMENTALThe women randomized to this arm will receive a ready-to-use-supplementary food (RUSF) designed specifically for pregnancy. The RUSF will provide a total of 520 kcal, 18 g protein, and 200% of recommended daily allowance (RDA) for most micronutrients during pregnancy. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition. These women will receive 5 anti-infective interventions: 1) insecticide-treated mosquito net, 2) monthly intermittent preventive treatment of malaria during pregnancy (IPTp) 3) azithromycin at the second and third trimester 4) albendazole given in second trimester, and 5) bacterial vaginosis testing and treatment at enrollment and again at weeks 28-34
Corn-soy-blend
ACTIVE COMPARATORThe women randomized to this arm will receive the standard of care for Sierra Leone. The treatment provided to women in this group includes 3.5 kg super cereal with 350 g vegetable oil every two weeks. This provides 250 mg portion/day of the super cereal and 25g oil/day for the mother. Women will receive the food for the duration of their pregnancy. These women will receive the current recommendations of the government of Sierra Leone, which includes standard intermittent preventive treatment of malaria during pregnancy (IPTp) of 2 doses of sulfadoxine/ pyrimethamine, iron and folic acid supplement with a goal of 90 pills/pregnancy, an insecticide-treated mosquito net, and albendazole for deworming in the second trimester.
Interventions
Specially formulated supplementary food for pregnancy
Standard of care for malnutrition in pregnancy in Sierra Leone
Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later.
Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
An insecticide-treated mosquito net at the time of enrollment into the study.
Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
Single dose albendazole 400mg given in the second trimester.
Testing for bacterial vaginosis at enrollment and again at weeks 28-34 using a rapid diagnostic test for sialidase. Those with positive tests will receive extended release metronidazole 750mg daily for 7 days.
Eligibility Criteria
You may qualify if:
- Pregnant women and consenting to study participation
- Fundal height not greater than 32 cm
- Mid-upper arm circumference ≤23 cm
- Planning to reside in the study area during pregnancy and 6 months post partum
- Attending 1 of the 40 antenatal clinic sites
You may not qualify if:
- \< 16 years of age without adult willing to consent
- Known pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1 Moriba Street
Pujehun, Pujehun District, Sierra Leone
Related Publications (3)
Hendrixson DT, Lasowski PN, Koroma AS, Manary MJ. Newborn Mid-Upper Arm Circumference Identifies Low-Birth Weight and Vulnerable Infants: A Secondary Analysis. Curr Dev Nutr. 2022 Sep 12;6(10):nzac138. doi: 10.1093/cdn/nzac138. eCollection 2022 Oct.
PMID: 36475019DERIVEDHendrixson DT, Smith K, Lasowski P, Callaghan-Gillespie M, Weber J, Papathakis P, Iversen PO, Koroma AS, Manary MJ. A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial. PLoS Med. 2021 Sep 28;18(9):e1003618. doi: 10.1371/journal.pmed.1003618. eCollection 2021 Sep.
PMID: 34582451DERIVEDHendrixson DT, Koroma AS, Callaghan-Gillespie M, Weber J, Papathakis P, Manary MJ. Use of a novel supplementary food and measures to control inflammation in malnourished pregnant women in Sierra Leone to improve birth outcomes: study protocol for a prospective, randomized, controlled clinical effectiveness trial. BMC Nutr. 2018 Apr 2;4:15. doi: 10.1186/s40795-018-0218-y. eCollection 2018.
PMID: 32153879DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mark J Manary, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2017
First Posted
March 14, 2017
Study Start
February 27, 2017
Primary Completion
September 24, 2019
Study Completion
February 24, 2020
Last Updated
January 7, 2021
Record last verified: 2021-01