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Trial record 34 of 117 for:    test | ( Map: Malawi )

The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds

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ClinicalTrials.gov Identifier: NCT02472301
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 9, 2015
First Posted Date  ICMJE June 15, 2015
Last Update Posted Date May 11, 2017
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
  • Dual Sugar Absorption Test [ Time Frame: 3 months ]
    lactulose-mannitol ratio in urine
  • Dual Sugar Absorption Test [ Time Frame: 6 months ]
    lactulose-mannitol ratio in urine
  • Dual Sugar Absorption Test [ Time Frame: 12 months ]
    lactulose-mannitol ratio in urine
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02472301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
  • Lactulose Excretion [ Time Frame: 3 months ]
    percentage of ingested lactulose excreted in urine
  • Lactulose Excretion [ Time Frame: 6 months ]
    percentage of ingested lactulose excreted in urine
  • Lactulose Excretion [ Time Frame: 12 months ]
    percentage of ingested lactulose excreted in urine
  • Mannitol Excretion [ Time Frame: 3 months ]
    percentage of ingested mannitol excreted in urine
  • Mannitol Excretion [ Time Frame: 6 months ]
    percentage of ingested mannitol excreted in urine
  • Mannitol Excretion [ Time Frame: 12 months ]
    percentage of ingested mannitol excreted in urine
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 The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds
Official Title  ICMJE Randomized, Single-blinded, Prospective Clinical Trial Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 1-3 Year Olds
Brief Summary To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Environmental Enteropathy
Intervention  ICMJE
  • Dietary Supplement: cowpeas complementary food
    cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
  • Dietary Supplement: corn-soy flour
    Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
  • Dietary Supplement: common bean complementary food
    common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Study Arms  ICMJE
  • Experimental: Cowpeas
    Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
    Intervention: Dietary Supplement: cowpeas complementary food
  • Experimental: Common bean
    Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
    Intervention: Dietary Supplement: common bean complementary food
  • Active Comparator: Corn Soy Flour
    Corn flour with 10% soy supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
    Intervention: Dietary Supplement: corn-soy flour
Publications *

*   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: November 9, 2016)
337
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2015)
300
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi
  • aged 12-35 months
  • youngest eligible child in each household

Exclusion Criteria:Unable to drink 20 mL of sugar water

  • Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
  • Apparent need for acute medical treatment for an illness or injury
  • Caregiver refusal to participate and return for 3, 6 and 12 month follow-ups
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02472301
Other Study ID Numbers  ICMJE LG2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Manary, MD Washington University School of Medince
PRS Account Washington University School of Medicine
Verification Date May 2017

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