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

K

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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