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

Malnutrition Clinical Trial

Official title:

Comparison of a Novel Fortified Blended Flour to Ready-to-use Supplemental Foods for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomized, Investigator-blinded, Clinical Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998517
• Other study ID #: SOYA2009
• Status: Completed
• Phase: N/A
• First received: October 19, 2009
• Last updated: April 14, 2014
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2712
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• WHZ <-2 but >-3 without bilateral pedal edema

• Reside within 7 kilometers of study site.

Exclusion Criteria:

• Not permanent resident in vicinity of study site.

• Severe chronic illness such as cerebral palsy.

• History of peanut allergy or anaphylaxis resulting from any food.

• Receiving other supplementary food or participating in other research.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Soy/peanut fortified spread
75kcal/kg/day
• Milk fortified corn/soy blend
75 kcal/kg/day
• Supplementary Plumpy®
75 kcal/kg/day

Locations

Country	Name	City	State
Malawi	University of Malawi College of Medicine	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Nutritional Recovery	Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length.; WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/	12 weeks or upon completion of recovery	No
Primary	Number of Patients With Absence of Bilateral Pedal Pitting Edema		12 weeks or recovery	No
Secondary	Rate of Weight Gain	This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks	4 weeks	No
Secondary	Number of Patients With Adverse Outcomes	This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.	12 months	No
Secondary	Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment		2 weeks	No
Secondary	Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)	Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up.	12 months	No
Secondary	Rates of Gain in Mid-upper Arm Circumference, and Length	These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks	4 weeks	No