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Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy Malnutrition in Pregnancy Nutrition Disorders Stunting Dietary Supplement: Ready-to-use-supplementary food Dietary Supplement: Corn-soy-blend Drug: Monthly intermittent preventive treatment of malaria during pregnancy (IPTp) Drug: Standard intermittent preventive treatment of malaria during pregnancy (IPTp) Other: Insecticide-treated mosquito net Drug: Azithromycin Drug: Albendazole Combination Product: Bacterial vaginosis testing and treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1489 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of the Use of Supplementary Food and Measures to Control Inflammation in Malnourished Pregnant Women to Improve Birth Outcomes
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : September 24, 2019
Actual Study Completion Date : February 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arms and Interventions
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Arm Intervention/treatment
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
 Dietary Supplement: Ready-to-use-supplementary food
Specially formulated supplementary food for pregnancy

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

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.
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.
 Dietary Supplement: Corn-soy-blend
Standard of care for malnutrition in pregnancy in Sierra Leone

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: Albendazole
Single dose albendazole 400mg given in the second trimester.


Outcome Measures
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Primary Outcome Measures :
  1. Infant birth length [ Time Frame: up to 40 weeks ]
    mean birth length of infants born to mothers in the study


Secondary Outcome Measures :
  1. Maternal weight gain [ Time Frame: up to 40 weeks ]
    Average weekly weight gain of women in the study

  2. Proportion recovered from maternal malnutrition [ Time Frame: up to 40 weeks ]
    proportion of women who reach mid-upper-arm circumference (MUAC) > 23 cm

  3. Premature delivery [ Time Frame: up to 36 weeks ]
    proportion of infants born prematurely

  4. Newborn head circumference [ Time Frame: up to 40 weeks ]
    mean head circumference of infants born to women in the study

  5. Infant birth weight [ Time Frame: up to 40 weeks ]
    mean birth weights of infants born to mothers in the study

  6. Infant weight at 6 weeks, 3 and 6 months [ Time Frame: up to 6 months ]
    infant ponderal growth

  7. Infant length at 6 weeks, 3 and 6 months [ Time Frame: up to 6 months ]
    infant linear growth

  8. Infant survival at 3 and 6 months [ Time Frame: up to 6 months ]
    survival of infants in the study


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be pregnant woman
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079388


Locations
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Sierra Leone
1 Moriba Street
Pujehun, Pujehun District, Sierra Leone
Sponsors and Collaborators
Washington University School of Medicine
The Children's Investment Fund Foundation
Investigators
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Study Chair: Mark J Manary, MD Washington University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03079388    
Other Study ID Numbers: 201611119
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Azithromycin
Pyrimethamine
Sulfadoxine
Albendazole
Fanasil, pyrimethamine drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
 Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents