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

Anemia, Iron-Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847962
• Other study ID #: FFE-621-2012/033-00
• Status: Completed
• Phase: N/A
• First received: July 20, 2016
• Last updated: July 25, 2016
• Start date: February 2016

Study information

• Verified date: July 2016
• Source: Kansas State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania and United States: Project Concern InternationalTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2179
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 53 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Avitaminosis
• Deficiency, Vitamin A
• Vitamin A Deficiency

Intervention

Other:
• Corn Soy Blend Plus (CSB+)

• Corn Soy Blend 14 (CSB14)

• White Sorghum Cowpea Blend Variety 1

• White Sorghum Cowpea Blend Variety 2

• Red Sorghum Cowpea Blend

• White Sorghum Soy Blend

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Kansas State University	National Institute for Medical Research, Tanzania, Project Concern International - Tanzania, United States Department of Agriculture Foreign Agricultural Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin Change		0, 10, 20 weeks (baseline, midline, and end line)	No
Primary	Dried blood spot retinol binding protein change	Assessment of vitamin A status	0, 10, 20 weeks (baseline, midline, and end line)	No
Secondary	Height-for-age change		0, 10, 20 weeks (baseline, midline, and end line)	No
Secondary	Weight-for-age change		0, 10, 20 weeks (baseline, midline, and end line)	No
Secondary	Weight-for-height change		0, 10, 20 weeks (baseline, midline, and end line)	No
Secondary	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)	No
Secondary	Mid-upper arm circumference change		0, 10, 20 weeks (baseline, midline, and end line)	No