Newly Formulated, Extruded Fortified-blended Foods for Food Aid: the MFFAPP Tanzania Efficacy Study

July 25, 2016 updated by: Brian Lindshield, Kansas State University
Corn-soy vitamin and mineral fortified blended foods (FBFs) are primarily used for food aid, although sorghum and cowpea may be suitable alternative FBF commodities. The objective of the Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania Efficacy Study is to determine whether newly formulated, extruded sorghum- and cowpea-based FBFs have equal, or better, nutritive value and acceptance compared to a traditional corn-soy blend. The effectiveness of each blend will be determined in an efficacy study of Tanzanian children under the age of 5 that are deficient, or at risk for deficiency, in iron and vitamin A.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2179

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hemoglobin <10.3mg/dl
  • Weight-for-height z-scores >-3

Exclusion Criteria:

  • Exclusive breastfeeding
  • Unwillingness to travel to health facilities
  • Enrollment of child in school during study period
  • Anticipated relocation of the family during the study
  • Allergy to the fortified-blended food product ingredients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control (No FBF)
FBF provided after the intervention period
Active Comparator: Corn Soy Blend Plus (CSB+)
Consumed Corn Soy Blend Plus (CSB+)
Other: Corn Soy Blend Plus (CSB+)
Experimental: Corn Soy Blend 14 (CSB14)
Consumed Corn Soy Blend 14 (CSB14)
Other: Corn Soy Blend 14 (CSB14)
Experimental: White Sorghum Cowpea Blend Variety 1
Consumed White Sorghum Cowpea Blend Variety 1
Other: White Sorghum Cowpea Blend Variety 1
Experimental: White Sorghum Cowpea Blend Variety 2
Consumed White Sorghum Cowpea Blend Variety 2
Other: White Sorghum Cowpea Blend Variety 2
Experimental: Red Sorghum Cowpea Blend
Consumed Red Sorghum Cowpea Blend
Other: Red Sorghum Cowpea Blend
Experimental: White Sorghum Soy Blend
Consumed White Sorghum Soy Blend
Other: White Sorghum Soy Blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Change
Time Frame: 0, 10, 20 weeks (baseline, midline, and end line)
0, 10, 20 weeks (baseline, midline, and end line)
Dried blood spot retinol binding protein change
Time Frame: 0, 10, 20 weeks (baseline, midline, and end line)
Assessment of vitamin A status
0, 10, 20 weeks (baseline, midline, and end line)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height-for-age change
Time Frame: 0, 10, 20 weeks (baseline, midline, and end line)
0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-age change
Time Frame: 0, 10, 20 weeks (baseline, midline, and end line)
0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-height change
Time Frame: 0, 10, 20 weeks (baseline, midline, and end line)
0, 10, 20 weeks (baseline, midline, and end line)
Moderate malnutrition status change
Time Frame: 0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-age between -3 and -2 z-scores below the median of the WHO child growth standards
0, 10, 20 weeks (baseline, midline, and end line)
Mid-upper arm circumference change
Time Frame: 0, 10, 20 weeks (baseline, midline, and end line)
0, 10, 20 weeks (baseline, midline, and end line)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas State University

Collaborators

National Institute for Medical Research, Tanzania
United States Department of Agriculture Foreign Agricultural Service
Project Concern International - Tanzania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFE-621-2012/033-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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