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

NCT ID: NCT00998517

Last Updated: 2014-05-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Soy/peanut fortified spread

Group Type ACTIVE_COMPARATOR

Soy/peanut fortified spread

Intervention Type DIETARY_SUPPLEMENT

75kcal/kg/day

Milk fortified corn/soy blend

Group Type EXPERIMENTAL

Milk fortified corn/soy blend

Intervention Type DIETARY_SUPPLEMENT

75 kcal/kg/day

Supplementary Plumpy®

Group Type ACTIVE_COMPARATOR

Supplementary Plumpy®

Intervention Type DIETARY_SUPPLEMENT

75 kcal/kg/day

Interventions

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Soy/peanut fortified spread

75kcal/kg/day

Intervention Type DIETARY_SUPPLEMENT

Milk fortified corn/soy blend

75 kcal/kg/day

Intervention Type DIETARY_SUPPLEMENT

Supplementary Plumpy®

75 kcal/kg/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Manary, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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University of Malawi College of Medicine

Blantyre, , Malawi

Site Status

Countries

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Malawi

References

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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.

Reference Type DERIVED
PMID: 25419681 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23256140 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22170366 (View on PubMed)

Other Identifiers

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SOYA2009

Identifier Type: -

Identifier Source: org_study_id

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