Trial record 8 of 141 for:    folic acid AND pregnancy NOT (male OR men)

Interventions for Moderate Malnutrition in Pregnancy (Mamachiponde)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02120599
First received: April 18, 2014
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pregnancy
Moderate Malnutrition
Dietary Supplement: ready-to-use supplementary food
Dietary Supplement: corn-soy blend
Dietary Supplement: iron
Dietary Supplement: folic acid
Dietary Supplement: UNIMMAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Proportion recovered from moderate acute malnutrition (MAM) [ Time Frame: up to 40 weeks ] [ Designated as safety issue: No ]
    proportion of women who reach mid-upper arm circumference (MUAC) > 23.5 cm for 2 consecutive visits

  • Maternal change in mid-upper arm circumference (MUAC) [ Time Frame: up to 40 weeks ] [ Designated as safety issue: No ]
    average change in mid-upper-arm circumference

  • infant birth weight [ Time Frame: up to 40 weeks ] [ Designated as safety issue: No ]
    mean birth weights of infants born to mothers in the study

  • infant birth length [ Time Frame: up to 40 weeks ] [ Designated as safety issue: No ]
    mean birth length of infants born to women in the study

  • premature delivery [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
    proportion of infants born prematurely


Secondary Outcome Measures:
  • maternal weight gain [ Time Frame: up to 40 weeks ] [ Designated as safety issue: No ]
  • maternal hemoglobin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    changes in average hemoglobin level

  • pregnancy complications [ Time Frame: up to 40 weeks ] [ Designated as safety issue: No ]
    rate of pregnancy complications

  • infant weight at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • infant length at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • infant survival at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: March 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: corn-soy-blend
This is the control group for the study, which will receive the Malawi standard of care. The treatment provided to women randomized to this arm of the study includes daily iron (60 mg) and folic acid (400 mcg) supplementation, along with 4 kg/2 weeks corn-soy blend (~357 gm/d CSB).
Dietary Supplement: corn-soy blend Dietary Supplement: iron Dietary Supplement: folic acid
Experimental: corn-soy-blend + multiple micronutrients
The treatment provided to women randomized to this arm of the study includes 200gm/d CSB along with a standard maternal multiple micronutrient tablet, which together provide a comparable amount of energy, protein and micronutrients to the ready-to-use supplemental food. The micronutrient supplement known as the United Nations Children's Emergency Fund (UNICEF) / World Health Organization (WHO) / United Nations University (UNU) international multiple micronutrient preparation (UNIMMAP) is widely available and has been used in many settings worldwide in pregnant women.
Dietary Supplement: corn-soy blend Dietary Supplement: UNIMMAP
Experimental: ready-to-use supplementary food
RUSF-P (ready-to-use supplementary food) provides 750 kcal/d, 20 g protein/d, and 200% of RDA/d for most micronutrients during pregnancy (except for vitamins A, B3, folic acid, minerals iodine, magnesium, and calcium which will remain near 100%)
Dietary Supplement: ready-to-use supplementary food

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02120599

Contacts
Contact: Peggy C Papathakis, PhD RD 805-756-7205 ppapatha@calpoly.edu

Locations
Malawi
Blantyre District Recruiting
Blantyre, Malawi
Chikwawa District Recruiting
Chikwawa, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Study Chair: Mark J Manary, MD Washington University in St. Louis; University of Malawi
Study Director: Peggy C Papathakis, PhD, RD California Polytechnic State University-San Luis Obispo
Principal Investigator: Kenneth Maleta, MBBS PhD University of Malawi
Principal Investigator: Chrissie Thakwalakwa University of Malawi
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02120599     History of Changes
Other Study ID Numbers: 201401112
Study First Received: April 18, 2014
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board
Malawi: College of Medicine Research and Ethics Committee

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Malnutrition
Nutrition Disorders
Micronutrients
Trace Elements
Vitamins
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014