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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 : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborators:
Arla Foods
University of Malawi College of Medicine
Project Peanut Butter
Information provided by (Responsible Party):
Washington University School of Medicine

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 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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: C-RUSF Dietary Supplement: HIPRO RUSF Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
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
Official Title: 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.
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Active Comparator: C-RUSF
Control/Standard RUSF
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

Active Comparator: HIPRO RUSF
New RUSF product
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03549156


Contacts
Contact: Mark Manary, MD 314 454 2178 manary@kids.wustl.edu

Locations
Malawi
Local Feeding Clinics Not yet recruiting
Blantyre, Malawi
Contact: Mark Manary         
Sponsors and Collaborators
Washington University School of Medicine
Arla Foods
University of Malawi College of Medicine
Project Peanut Butter
Investigators
Principal Investigator: Mark Manary, MD Washington University School of Medicine in St. Louis

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03549156     History of Changes
Other Study ID Numbers: 201805096
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
Moderate Acute Malnutrition, Malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders