Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00998517
First received: October 19, 2009
Last updated: April 14, 2014
Last verified: April 2014
Results First Received: August 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Malnutrition
Interventions: Dietary Supplement: Soy/peanut fortified spread
Dietary Supplement: Milk fortified corn/soy blend
Dietary Supplement: Supplementary Plumpy®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Milk Fortified Corn/Soy Blend Milk fortified corn/soy blend : 75 kcal/kg/day
Soy/Peanut Fortified Spread Soy/peanut fortified spread : 75kcal/kg/day
Supplementary Plumpy® Supplementary Plumpy® : 75 kcal/kg/day

Participant Flow:   Overall Study
    Milk Fortified Corn/Soy Blend     Soy/Peanut Fortified Spread     Supplementary Plumpy®  
STARTED     888     906     918  
COMPLETED     888     906     918  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Milk Fortified Corn/Soy Blend Milk fortified corn/soy blend : 75 kcal/kg/day
Soy/Peanut Fortified Spread Soy/peanut fortified spread : 75kcal/kg/day
Supplementary Plumpy® Supplementary Plumpy® : 75 kcal/kg/day
Total Total of all reporting groups

Baseline Measures
    Milk Fortified Corn/Soy Blend     Soy/Peanut Fortified Spread     Supplementary Plumpy®     Total  
Number of Participants  
[units: participants]
  888     906     918     2712  
Age  
[units: participants]
       
<=18 years     888     906     918     2712  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  1.63  ± 0.92     1.63  ± 0.9     1.61  ± 0.92     1.62  ± 0.91  
Gender  
[units: participants]
       
Female     539     562     583     1684  
Male     349     344     335     1028  
Region of Enrollment  
[units: participants]
       
Malawi     888     906     918     2712  



  Outcome Measures
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1.  Primary:   Number of Participants With Nutritional Recovery   [ Time Frame: 12 weeks or upon completion of recovery ]

2.  Primary:   Number of Patients With Absence of Bilateral Pedal Pitting Edema   [ Time Frame: 12 weeks or recovery ]

3.  Secondary:   Rate of Weight Gain   [ Time Frame: 4 weeks ]

4.  Secondary:   Number of Patients With Adverse Outcomes   [ Time Frame: 12 months ]

5.  Secondary:   Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment   [ Time Frame: 2 weeks ]

6.  Secondary:   Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)   [ Time Frame: 12 months ]

7.  Secondary:   Rates of Gain in Mid-upper Arm Circumference, and Length   [ Time Frame: 4 weeks ]


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  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Indi Trehan
Organization: Washington University in St. Louis
phone: 5039284634
e-mail: itrehan@wustl.edu


No publications provided by Washington University School of Medicine

Publications automatically indexed to this study:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00998517     History of Changes
Other Study ID Numbers: SOYA2009
Study First Received: October 19, 2009
Results First Received: August 15, 2012
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board