Clinical trial NCT02847962: Newly Formulated, Extruded Fortified-blended Foods for Food Aid: the MFFAPP Tanzania Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Kansas State University
Sponsor class: OTHER
Collaborators: name: Project Concern International - Tanzania
name: National Institute for Medical Research, Tanzania
name: United States Department of Agriculture Foreign Agricultural Service
First posted: 2016-07-28
Enrollment: 2179
Sex: ALL
Minimum age (years): 6
Maximum age (years): 53
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin Change
timeFrame: 0, 10, 20 weeks (baseline, midline, and end line)
measure: Dried blood spot retinol binding protein change
timeFrame: 0, 10, 20 weeks (baseline, midline, and end line)
Secondary outcomes:
measure: Height-for-age change
timeFrame: 0, 10, 20 weeks (baseline, midline, and end line)
measure: Weight-for-age change
timeFrame: 0, 10, 20 weeks (baseline, midline, and end line)
measure: Weight-for-height change
timeFrame: 0, 10, 20 weeks (baseline, midline, and end line)
measure: Moderate malnutrition status change
timeFrame: 0, 10, 20 weeks (baseline, midline, and end line)
measure: Mid-upper arm circumference change
timeFrame: 0, 10, 20 weeks (baseline, midline, and end line)
Other outcomes:
Locations:
Study officials:
References:
citation: Delimont NM, Vahl CI, Kayanda R, Msuya W, Mulford M, Alberghine P, Praygod G, Mngara J, Alavi S, Lindshield BL. Complementary Feeding of Sorghum-Based and Corn-Based Fortified Blended Foods Results in Similar Iron, Vitamin A, and Anthropometric Outcomes in the MFFAPP Tanzania Efficacy Study. Curr Dev Nutr. 2019 Apr 10;3(6):nzz027. doi: 10.1093/cdn/nzz027. eCollection 2019 Jun.
citation: Delimont NM, Chanadang S, Joseph MV, Rockler BE, Guo Q, Regier GK, Mulford MR, Kayanda R, Range M, Mziray Z, Jonas A, Mugyabuso J, Msuya W, Lilja NK, Procter SB, Chambers E 4th, Alavi S, Lindshield BL. The MFFAPP Tanzania Efficacy Study Protocol: Newly Formulated, Extruded, Fortified Blended Foods for Food Aid. Curr Dev Nutr. 2017 Apr 25;1(5):e000315. doi: 10.3945/cdn.116.000315. eCollection 2017 May.