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Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of MAM.

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ClinicalTrials.gov Identifier: NCT03549156
Recruitment Status : Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
Arla Foods
University of Malawi College of Medicine
Project Peanut Butter
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE May 18, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE June 25, 2018
Actual Primary Completion Date March 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
Recovery from Moderate Acute Malnutrition using Mid-Upper Arm Circumference (MUAC) and Weight for Height Z score (WHZ) [ Time Frame: 12 weeks ]
Number of participants achieving a Mid-Upper Arm Circumference (MUAC) ≥ 12.5 cm and/or WHZ>-2 within a 12 week treatment period
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Recovery from Moderate Acute Malnutrition using Mid-Upper Arm Circumference (MUAC) [ Time Frame: 12 weeks ]
Number of participants achieving a Mid-Upper Arm Circumference (MUAC) ≥ 12.5 cm within a 12 week treatment period.
Change History Complete list of historical versions of study NCT03549156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of MAM.
Official Title  ICMJE Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomised, Investigator-blinded, Clinical Effectiveness Trial.
Brief Summary This is a prospective, randomised, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM. The setting will be 21 rural sites in southern Malawi. The participants will be 1800 children 6-59 months old with MAM, defined as mid-upper arm circumference (MUAC) ≥ 11.5 cm and < 12.5 cm and/or a weight-for-height Z-score (WHZ) between -2 and -3 without bipedal edema. Children will receive approximately 75 kcal/kg/d (314 kJ/kg/d) of one of two RUSFs in two-week rations for outpatient therapy of MAM. The two supplements will be a novel, locally produced peanut/dairy RUSFs, one with a high protein quality (HIPRO RUSF) or one with a standard protein quality, referred to as control RUSF (C-RUSF). The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm and/or WHZ>-2 by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default). Secondary outcome measures include rates of weight, height, and mid-upper-arm circumference (MUAC) gain, time to graduation, and adverse effects from the supplementary foods.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Each food will be randomized to two colors with the study coordinator, nurse, caregivers blinded to the which color is which food.
Primary Purpose: Treatment
Condition  ICMJE Malnutrition
Intervention  ICMJE
  • Dietary Supplement: C-RUSF
    -RUSF contains whey permeate, WPC 80, peanut paste, sugar, soy oil, canola oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier
    Other Name: Ready-to-use supplementary food
  • Dietary Supplement: HIPRO RUSF
    HIPRO RUSF contains extruded soy flour, skimmed milk, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate
    Other Name: Ready-to-use supplementary food
Study Arms  ICMJE
  • Active Comparator: C-RUSF
    Control/Standard RUSF
    Intervention: Dietary Supplement: C-RUSF
  • Active Comparator: HIPRO RUSF
    New RUSF product
    Intervention: Dietary Supplement: HIPRO RUSF
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 9, 2019)
1858
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
1800
Estimated Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date March 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • MUAC < 12.5 cm and ≥ 11.5 cm
  • without bipedal edema

Exclusion Criteria:

  • simultaneously involved in another research trial or supplemental feeding program
  • developmentally delayed, have a chronic debilitating illness such as cerebral palsy
  • history of peanut or milk allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
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 NCT03549156
Other Study ID Numbers  ICMJE 201805096
Has Data Monitoring Committee No
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
  • Arla Foods
  • University of Malawi College of Medicine
  • Project Peanut Butter
Investigators  ICMJE
Principal Investigator: Mark Manary, MD Washington University School of Medicine in St. Louis
PRS Account Washington University School of Medicine
Verification Date June 2019

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