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NCT Number: NCT02847962

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

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.

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Key information

Conditions

Anemia, Iron-Deficiency Anemia Anemia, Hypochromic Avitaminosis Body Weight Body Weight Changes Cachexia Callosities Deficiency Diseases Deficiency, Vitamin A Growth Disorders Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Keratosis Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protein Deficiency Protein-Energy Malnutrition Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Thinness Vitamin A Deficiency Weight Loss

Age range

6 month–53 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corn Soy Blend Plus (CSB+)

Other

Corn Soy Blend 14 (CSB14)

Other

White Sorghum Cowpea Blend Variety 1

Other

White Sorghum Cowpea Blend Variety 2

Other

Red Sorghum Cowpea Blend

Other

White Sorghum Soy Blend

Other

Primary outcomes

  1. Hemoglobin Change

    Time frame: 0, 10, 20 weeks (baseline, midline, and end line)

  2. Dried blood spot retinol binding protein change

    Time frame: 0, 10, 20 weeks (baseline, midline, and end line)

    Assessment of vitamin A status

Secondary outcomes

  1. Height-for-age change

    Time frame: 0, 10, 20 weeks (baseline, midline, and end line)

  2. Weight-for-age change

    Time frame: 0, 10, 20 weeks (baseline, midline, and end line)

  3. Weight-for-height change

    Time frame: 0, 10, 20 weeks (baseline, midline, and end line)

  4. Moderate malnutrition status change

    Time frame: 0, 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

  5. Mid-upper arm circumference change

    Time frame: 0, 10, 20 weeks (baseline, midline, and end line)

Sponsors and collaborators

Lead sponsor

Kansas State University

Other

Collaborators

  • National Institute for Medical Research, Tanzania
  • Project Concern International - Tanzania
  • United States Department of Agriculture Foreign Agricultural Service

Registry information

Important dates

Study start
2016
Primary completion
2016
First posted
Jul 28, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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