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Trial record 1 of 1 for:    NCT03079388
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Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)

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ClinicalTrials.gov Identifier: NCT03079388
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
The Children's Investment Fund Foundation
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 5, 2017
First Posted Date  ICMJE March 14, 2017
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE February 27, 2017
Actual Primary Completion Date September 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
Infant birth length [ Time Frame: up to 40 weeks ]
mean birth length of infants born to mothers in the study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • Maternal weight gain [ Time Frame: up to 40 weeks ]
    Average weekly weight gain of women in the study
  • Proportion recovered from maternal malnutrition [ Time Frame: up to 40 weeks ]
    proportion of women who reach mid-upper-arm circumference (MUAC) > 23 cm
  • Premature delivery [ Time Frame: up to 36 weeks ]
    proportion of infants born prematurely
  • Newborn head circumference [ Time Frame: up to 40 weeks ]
    mean head circumference of infants born to women in the study
  • Infant birth weight [ Time Frame: up to 40 weeks ]
    mean birth weights of infants born to mothers in the study
  • Infant weight at 6 weeks, 3 and 6 months [ Time Frame: up to 6 months ]
    infant ponderal growth
  • Infant length at 6 weeks, 3 and 6 months [ Time Frame: up to 6 months ]
    infant linear growth
  • Infant survival at 3 and 6 months [ Time Frame: up to 6 months ]
    survival of infants in the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)
Official Title  ICMJE Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pregnancy
  • Malnutrition in Pregnancy
  • Nutrition Disorders
  • Stunting
Intervention  ICMJE
  • Dietary Supplement: Ready-to-use-supplementary food
    Specially formulated supplementary food for pregnancy
  • Dietary Supplement: Corn-soy-blend
    Standard of care for malnutrition in pregnancy in Sierra Leone
  • Drug: Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)
    Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later.
    Other Name: Sulfadoxine-pyrimethamine
  • Drug: Standard intermittent preventive treatment of malaria during pregnancy (IPTp)
    Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
    Other Name: Sulfadoxine-pyrimethamine
  • Other: Insecticide-treated mosquito net
    An insecticide-treated mosquito net at the time of enrollment into the study.
  • Drug: Azithromycin
    Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
  • Drug: Albendazole
    Single dose albendazole 400mg given in the second trimester.
  • Combination Product: Bacterial vaginosis testing and treatment
    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.
Study Arms  ICMJE
  • Experimental: Ready-to-use supplementary food + anti-infective bundle
    The 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
    Interventions:
    • Dietary Supplement: Ready-to-use-supplementary food
    • Drug: Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)
    • Other: Insecticide-treated mosquito net
    • Drug: Azithromycin
    • Drug: Albendazole
    • Combination Product: Bacterial vaginosis testing and treatment
  • Active Comparator: Corn-soy-blend
    The 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:
    • Dietary Supplement: Corn-soy-blend
    • Drug: Standard intermittent preventive treatment of malaria during pregnancy (IPTp)
    • Other: Insecticide-treated mosquito net
    • Drug: Albendazole
Publications * Hendrixson 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2020)
1489
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2017)
1514
Actual Study Completion Date  ICMJE February 24, 2020
Actual Primary Completion Date September 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • < 16 years of age without adult willing to consent
  • Known pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Must be pregnant woman
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sierra Leone
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03079388
Other Study ID Numbers  ICMJE 201611119
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE The Children's Investment Fund Foundation
Investigators  ICMJE
Study Chair: Mark J Manary, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP