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

Kansas State University

Status: Completed

Conditions: Deficiency, Vitamin A; Anemia, Iron-Deficiency

Treatments: Other: Corn Soy Blend Plus (CSB+); Other: Corn Soy Blend 14 (CSB14); Other: White Sorghum Cowpea Blend Variety 1; Other: White Sorghum Soy Blend; Other: Red Sorghum Cowpea Blend; Other: White Sorghum Cowpea Blend Variety 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02847962

FFE-621-2012/033-00

Details and patient eligibility

About

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.

Enrollment: 2,179 patients

Sex: All

Ages: 6 to 53 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,179 participants in 7 patient groups

Control (No FBF)

No Intervention group

Description:

FBF provided after the intervention period

Corn Soy Blend Plus (CSB+)

Active Comparator group

Description:

Consumed Corn Soy Blend Plus (CSB+)

Treatment:

Other: Corn Soy Blend Plus (CSB+)

Corn Soy Blend 14 (CSB14)

Experimental group

Description:

Consumed Corn Soy Blend 14 (CSB14)

Treatment:

Other: Corn Soy Blend 14 (CSB14)

White Sorghum Cowpea Blend Variety 1

Experimental group

Description:

Consumed White Sorghum Cowpea Blend Variety 1

Treatment:

Other: White Sorghum Cowpea Blend Variety 1

White Sorghum Cowpea Blend Variety 2

Experimental group

Description:

Consumed White Sorghum Cowpea Blend Variety 2

Treatment:

Other: White Sorghum Cowpea Blend Variety 2

Red Sorghum Cowpea Blend

Experimental group

Description:

Consumed Red Sorghum Cowpea Blend

Treatment:

Other: Red Sorghum Cowpea Blend

White Sorghum Soy Blend

Experimental group

Description:

Consumed White Sorghum Soy Blend

Treatment:

Other: White Sorghum Soy Blend