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

Not Applicable

Completed

• Conditions: Deficiency, Vitamin A; Anemia, Iron-Deficiency
• Interventions: Other: Red Sorghum Cowpea Blend; Other: Corn Soy Blend Plus (CSB+); Other: Corn Soy Blend 14 (CSB14); Other: White Sorghum Cowpea Blend Variety 1; Other: White Sorghum Cowpea Blend Variety 2; Other: White Sorghum Soy Blend

• Registration Number: NCT02847962
• Lead Sponsor: Kansas State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2179

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Red Sorghum Cowpea Blend	Red Sorghum Cowpea Blend	Consumed Red Sorghum Cowpea Blend
Corn Soy Blend Plus (CSB+)	Corn Soy Blend Plus (CSB+)	Consumed Corn Soy Blend Plus (CSB+)
Corn Soy Blend 14 (CSB14)	Corn Soy Blend 14 (CSB14)	Consumed Corn Soy Blend 14 (CSB14)
White Sorghum Cowpea Blend Variety 1	White Sorghum Cowpea Blend Variety 1	Consumed White Sorghum Cowpea Blend Variety 1
White Sorghum Cowpea Blend Variety 2	White Sorghum Cowpea Blend Variety 2	Consumed White Sorghum Cowpea Blend Variety 2
White Sorghum Soy Blend	White Sorghum Soy Blend	Consumed White Sorghum Soy Blend

Primary Outcome Measures

Name	Time	Method
Hemoglobin Change	0, 10, 20 weeks (baseline, midline, and end line)
Dried blood spot retinol binding protein change	0, 10, 20 weeks (baseline, midline, and end line)	Assessment of vitamin A status

Secondary Outcome Measures

Name	Time	Method
Height-for-age change	0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-age change	0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-height change	0, 10, 20 weeks (baseline, midline, and end line)
Moderate malnutrition status change	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
Mid-upper arm circumference change	0, 10, 20 weeks (baseline, midline, and end line)