NCT00998517

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,712

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 12, 2014

Completed
Last Updated

May 12, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

October 19, 2009

Results QC Date

August 15, 2012

Last Update Submit

April 14, 2014

Conditions

Malnutrition

Keywords

MalnutritionSupplemental FoodCSB++Supplementary Plumpy

Outcome Measures

Primary Outcomes (2)

  • 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

  • Number of Patients With Absence of Bilateral Pedal Pitting Edema

    12 weeks or recovery

Secondary Outcomes (5)

  • Rate of Weight Gain

    4 weeks

  • Number of Patients With Adverse Outcomes

    12 months

  • Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment

    2 weeks

  • Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)

    12 months

  • Rates of Gain in Mid-upper Arm Circumference, and Length

    4 weeks

Study Arms (3)

Soy/peanut fortified spread

ACTIVE COMPARATOR
Dietary Supplement: Soy/peanut fortified spread

Milk fortified corn/soy blend

EXPERIMENTAL
Dietary Supplement: Milk fortified corn/soy blend

Supplementary Plumpy®

ACTIVE COMPARATOR
Dietary Supplement: Supplementary Plumpy®

Interventions

Soy/peanut fortified spreadDIETARY_SUPPLEMENT

75kcal/kg/day

Soy/peanut fortified spread
Milk fortified corn/soy blendDIETARY_SUPPLEMENT

75 kcal/kg/day

Milk fortified corn/soy blend
Supplementary Plumpy®DIETARY_SUPPLEMENT

75 kcal/kg/day

Supplementary Plumpy®

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • WHZ \<-2 but \>-3 without bilateral pedal edema
  • Reside within 7 kilometers of study site.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malawi College of Medicine

Blantyre, 03, Malawi

Location

Related Publications (3)

  • Trehan I, Banerjee S, Murray E, Ryan KN, Thakwalakwa C, Maleta KM, Manary MJ. Extending supplementary feeding for children younger than 5 years with moderate acute malnutrition leads to lower relapse rates. J Pediatr Gastroenterol Nutr. 2015 Apr;60(4):544-9. doi: 10.1097/MPG.0000000000000639.

    PMID: 25419681DERIVED

  • Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.

    PMID: 23256140DERIVED

  • LaGrone LN, Trehan I, Meuli GJ, Wang RJ, Thakwalakwa C, Maleta K, Manary MJ. A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Am J Clin Nutr. 2012 Jan;95(1):212-9. doi: 10.3945/ajcn.111.022525. Epub 2011 Dec 14.

    PMID: 22170366DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Indi Trehan
Organization
Washington University in St. Louis
itrehan@wustl.edu
5039284634

Study Officials

  • Mark J Manary, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 20, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 12, 2014

Results First Posted

May 12, 2014

Record last verified: 2014-04

Locations

MA(1)