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

Study Overview
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Brief Summary
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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.

Conditions
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Anemia, Iron-Deficiency, Deficiency, Vitamin A

Intervention / Treatment
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* 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: Red Sorghum Cowpea Blend
* Other: White Sorghum Soy Blend


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 53 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Change |  | 0, 10, 20 weeks (baseline, midline, and end line) | 
| Dried blood spot retinol binding protein change | 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 |  | 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 | 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 |  | 0, 10, 20 weeks (baseline, midline, and end line) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fortified-blended foods, Extrusion, Sorghum, Cowpea, Vitamin A, Iron, Protein, Food Aid, Anemia, Iron-Deficiency, Deficiency, Vitamin A, Growth Velocity, Stunting, Wasting, Protein-Energy Malnutrition, Complementary Feeding, Corn, Soy, Fortified Foods, Food assistance