NCT01898871

Brief Summary

The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

February 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

July 10, 2013

Last Update Submit

July 10, 2013

Conditions

WastingModerate Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Recovery rate of the children receiving CSB+ or RUSF

    Children with Weight-for-Height Z-score \> -2

    56 days

Study Arms (2)

Ready to Use Suplementary Food (RUSF)

EXPERIMENTAL

A daily ration of 40 kcal/kg of body weight during 56 days

Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 days

Corn Soya Blend (CSB+)

ACTIVE COMPARATOR

A daily ration of 40 kcal/kg of body weight during 56 days

Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 days

Interventions

A daily ration of 40 kcal/kg of body weight during 56 daysDIETARY_SUPPLEMENT

On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.

Corn Soya Blend (CSB+)Ready to Use Suplementary Food (RUSF)

Eligibility Criteria

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

You may qualify if:

  • Children aged 6-59 month
  • Weight-for-height between -3 and -2 z-scores without edema
  • Good appetite
  • Stable clinical conditions

You may not qualify if:

  • Weight-for-Height Z-score \< -3
  • Presence of bilateral pitting edema
  • Unstable clinical conditions
  • Not showing appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Evodoula Health District

Évodoula, Cameroon

Location

Biyem Assi District Centre

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Gabriel Medoua Nama, Ph.D.

    Centre for Food and Nutrition Research, IMPM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of Centre

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 12, 2013

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

CA(2)