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

Primary Purpose

Anemia, Iron-Deficiency, Deficiency, Vitamin A

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Sponsored by
Kansas State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Iron-Deficiency focused on measuring 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

Eligibility Criteria

6 Months - 53 Months (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    No Intervention

    Active Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Control (No FBF)

    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

    Arm Description

    FBF provided after the intervention period

    Consumed Corn Soy Blend Plus (CSB+)

    Consumed Corn Soy Blend 14 (CSB14)

    Consumed White Sorghum Cowpea Blend Variety 1

    Consumed White Sorghum Cowpea Blend Variety 2

    Consumed Red Sorghum Cowpea Blend

    Consumed White Sorghum Soy Blend

    Outcomes

    Primary Outcome Measures

    Hemoglobin Change
    Dried blood spot retinol binding protein change
    Assessment of vitamin A status

    Secondary Outcome Measures

    Height-for-age change
    Weight-for-age change
    Weight-for-height change
    Moderate malnutrition status change
    Weight-for-age between -3 and -2 z-scores below the median of the WHO child growth standards
    Mid-upper arm circumference change

    Full Information

    First Posted
    July 20, 2016
    Last Updated
    July 25, 2016
    Sponsor
    Kansas State University
    Collaborators
    Project Concern International - Tanzania, National Institute for Medical Research, Tanzania, United States Department of Agriculture Foreign Agricultural Service
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02847962
    Brief Title
    Newly Formulated, Extruded Fortified-blended Foods for Food Aid: the MFFAPP Tanzania Efficacy Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kansas State University
    Collaborators
    Project Concern International - Tanzania, National Institute for Medical Research, Tanzania, United States Department of Agriculture Foreign Agricultural Service

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2179 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control (No FBF)
    Arm Type
    No Intervention
    Arm Description
    FBF provided after the intervention period
    Arm Title
    Corn Soy Blend Plus (CSB+)
    Arm Type
    Active Comparator
    Arm Description
    Consumed Corn Soy Blend Plus (CSB+)
    Arm Title
    Corn Soy Blend 14 (CSB14)
    Arm Type
    Experimental
    Arm Description
    Consumed Corn Soy Blend 14 (CSB14)
    Arm Title
    White Sorghum Cowpea Blend Variety 1
    Arm Type
    Experimental
    Arm Description
    Consumed White Sorghum Cowpea Blend Variety 1
    Arm Title
    White Sorghum Cowpea Blend Variety 2
    Arm Type
    Experimental
    Arm Description
    Consumed White Sorghum Cowpea Blend Variety 2
    Arm Title
    Red Sorghum Cowpea Blend
    Arm Type
    Experimental
    Arm Description
    Consumed Red Sorghum Cowpea Blend
    Arm Title
    White Sorghum Soy Blend
    Arm Type
    Experimental
    Arm Description
    Consumed White Sorghum Soy Blend
    Intervention Type
    Other
    Intervention Name(s)
    Corn Soy Blend Plus (CSB+)
    Intervention Type
    Other
    Intervention Name(s)
    Corn Soy Blend 14 (CSB14)
    Intervention Type
    Other
    Intervention Name(s)
    White Sorghum Cowpea Blend Variety 1
    Intervention Type
    Other
    Intervention Name(s)
    White Sorghum Cowpea Blend Variety 2
    Intervention Type
    Other
    Intervention Name(s)
    Red Sorghum Cowpea Blend
    Intervention Type
    Other
    Intervention Name(s)
    White Sorghum Soy Blend
    Primary Outcome Measure Information:
    Title
    Hemoglobin Change
    Time Frame
    0, 10, 20 weeks (baseline, midline, and end line)
    Title
    Dried blood spot retinol binding protein change
    Description
    Assessment of vitamin A status
    Time Frame
    0, 10, 20 weeks (baseline, midline, and end line)
    Secondary Outcome Measure Information:
    Title
    Height-for-age change
    Time Frame
    0, 10, 20 weeks (baseline, midline, and end line)
    Title
    Weight-for-age change
    Time Frame
    0, 10, 20 weeks (baseline, midline, and end line)
    Title
    Weight-for-height change
    Time Frame
    0, 10, 20 weeks (baseline, midline, and end line)
    Title
    Moderate malnutrition status change
    Description
    Weight-for-age between -3 and -2 z-scores below the median of the WHO child growth standards
    Time Frame
    0, 10, 20 weeks (baseline, midline, and end line)
    Title
    Mid-upper arm circumference change
    Time Frame
    0, 10, 20 weeks (baseline, midline, and end line)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    53 Months
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31143849
    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.
    Results Reference
    derived
    PubMed Identifier
    29955700
    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.
    Results Reference
    derived

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

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