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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02847962
Enrollment
2179
Registered
2016-07-28
Start date
2016-02-29
Completion date
Unknown
Last updated
2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron-Deficiency, Deficiency, Vitamin A

Keywords

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

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.

Interventions

OTHERCorn Soy Blend Plus (CSB+)
OTHERCorn Soy Blend 14 (CSB14)
OTHERWhite Sorghum Cowpea Blend Variety 1
OTHERWhite Sorghum Cowpea Blend Variety 2
OTHERRed Sorghum Cowpea Blend
OTHERWhite Sorghum Soy Blend

Sponsors

Project Concern International - Tanzania
CollaboratorUNKNOWN
National Institute for Medical Research, Tanzania
CollaboratorOTHER_GOV
United States Department of Agriculture Foreign Agricultural Service
CollaboratorOTHER
Kansas State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 53 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin Change0, 10, 20 weeks (baseline, midline, and end line)
Dried blood spot retinol binding protein change0, 10, 20 weeks (baseline, midline, and end line)Assessment of vitamin A status

Secondary

MeasureTime frameDescription
Weight-for-height change0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-age change0, 10, 20 weeks (baseline, midline, and end line)
Mid-upper arm circumference change0, 10, 20 weeks (baseline, midline, and end line)
Moderate malnutrition status change0, 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
Height-for-age change0, 10, 20 weeks (baseline, midline, and end line)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026