Anemia, Iron-DeficiencyNCT02847962
Newly Formulated, Extruded Fortified-blended Foods for Food Aid: the MFFAPP Tanzania Efficacy Study
A study testing Corn Soy Blend Plus (CSB+), Corn Soy Blend 14 (CSB14) and White Sorghum Cowpea Blend Variety 1 in people with Anemia, Iron-Deficiency and Deficiency, Vitamin A, run by Kansas State University.
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… Read more about this study
- Who is it for?
- Ages 6 to 53 months
- Conditions the study is for
- Anemia, Iron-Deficiency, Deficiency, Vitamin A
- What is being tested?
- Corn Soy Blend Plus (CSB+), Corn Soy Blend 14 (CSB14) and White Sorghum Cowpea Blend Variety 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,179 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 53 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hemoglobin <10.3mg/dl
- Weight-for-height z-scores >-3
Who cannot join
- 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
About this 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.
- Conditions
- Anemia, Iron-Deficiency, Deficiency, Vitamin A
- Being tested
- 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
- 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
- Medical subject headings
- Anemia, Iron-Deficiency, Vitamin A Deficiency, Growth Disorders, Cachexia, Protein-Energy Malnutrition, Callosities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn Soy Blend Plus (CSB+)Other
Corn Soy Blend 14 (CSB14)Other
White Sorghum Cowpea Blend Variety 1Other
White Sorghum Cowpea Blend Variety 2Other
Red Sorghum Cowpea BlendOther
White Sorghum Soy BlendOther
| Study group | Role | What they receive |
|---|---|---|
| Control (No FBF) | No intervention | FBF provided after the intervention period |
| Corn Soy Blend Plus (CSB+) | Active comparator | Consumed Corn Soy Blend Plus (CSB+) Receives: Other: Corn Soy Blend Plus (CSB+) |
| Corn Soy Blend 14 (CSB14) | Experimental | Consumed Corn Soy Blend 14 (CSB14) Receives: Other: Corn Soy Blend 14 (CSB14) |
| White Sorghum Cowpea Blend Variety 1 | Experimental | Consumed White Sorghum Cowpea Blend Variety 1 Receives: Other: White Sorghum Cowpea Blend Variety 1 |
| White Sorghum Cowpea Blend Variety 2 | Experimental | Consumed White Sorghum Cowpea Blend Variety 2 Receives: Other: White Sorghum Cowpea Blend Variety 2 |
| Red Sorghum Cowpea Blend | Experimental | Consumed Red Sorghum Cowpea Blend Receives: Other: Red Sorghum Cowpea Blend |
| White Sorghum Soy Blend | Experimental | Consumed White Sorghum Soy Blend Receives: Other: White Sorghum Soy Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Change
Measured: 0, 10, 20 weeks (baseline, midline, and end line)
Dried blood spot retinol binding protein change
Assessment of vitamin A status
Measured: 0, 10, 20 weeks (baseline, midline, and end line)
Secondary outcomes (5)
Height-for-age change
Measured: 0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-age change
Measured: 0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-height change
Measured: 0, 10, 20 weeks (baseline, midline, and end line)
Moderate malnutrition status change
Weight-for-age between -3 and -2 z-scores below the median of the WHO child growth standards
Measured: 0, 10, 20 weeks (baseline, midline, and end line)
Mid-upper arm circumference change
Measured: 0, 10, 20 weeks (baseline, midline, and end line)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Collaborators
- Project Concern International - Tanzania, National Institute for Medical Research, Tanzania, United States Department of Agriculture Foreign Agricultural Service
- Responsible party
- Principal investigator, Brian Lindshield, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847962
- Sponsor's protocol ID
- FFE-621-2012/033-00
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31143849Delimont 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.
PubMed 29955700
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newly Formulated, Extruded Fortified-blended Foods for Food Aid: the MFFAPP Tanzania Efficacy Study
- ClinicalTrials.gov ID
- NCT02847962
- Acronym / sponsor ID
- FFE-621-2012/033-00
- Conditions
- Anemia, Iron-Deficiency, Deficiency, Vitamin A
- Keywords
- Fortified-blended foods, Extrusion, Sorghum, Cowpea, Vitamin A, Iron, Protein, Food Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,179 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- Project Concern International - Tanzania, National Institute for Medical Research, Tanzania, United States Department of Agriculture Foreign Agricultural Service
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control (No FBF) | No intervention | –FBF provided after the intervention period |
| Corn Soy Blend Plus (CSB+) | Active comparator | Other: Corn Soy Blend Plus (CSB+)Consumed Corn Soy Blend Plus (CSB+) |
| Corn Soy Blend 14 (CSB14) | Experimental | Other: Corn Soy Blend 14 (CSB14)Consumed Corn Soy Blend 14 (CSB14) |
| White Sorghum Cowpea Blend Variety 1 | Experimental | Other: White Sorghum Cowpea Blend Variety 1Consumed White Sorghum Cowpea Blend Variety 1 |
| White Sorghum Cowpea Blend Variety 2 | Experimental | Other: White Sorghum Cowpea Blend Variety 2Consumed White Sorghum Cowpea Blend Variety 2 |
| Red Sorghum Cowpea Blend | Experimental | Other: Red Sorghum Cowpea BlendConsumed Red Sorghum Cowpea Blend |
| White Sorghum Soy Blend | Experimental | Other: White Sorghum Soy BlendConsumed White Sorghum Soy Blend |
Who may qualify
- Ages
- 6 to 53 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Hemoglobin <10.3mg/dl
- Weight-for-height z-scores >-3
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corn Soy Blend Plus (CSB+) | Other | Corn Soy Blend Plus (CSB+) |
| Corn Soy Blend 14 (CSB14) | Other | Corn Soy Blend 14 (CSB14) |
| White Sorghum Cowpea Blend Variety 1 | Other | White Sorghum Cowpea Blend Variety 1 |
| White Sorghum Cowpea Blend Variety 2 | Other | White Sorghum Cowpea Blend Variety 2 |
| Red Sorghum Cowpea Blend | Other | Red Sorghum Cowpea Blend |
| White Sorghum Soy Blend | Other | White Sorghum Soy Blend |
Primary outcome
Hemoglobin Change
Time frame: 0, 10, 20 weeks (baseline, midline, and end line)
Dried blood spot retinol binding protein change
Time frame: 0, 10, 20 weeks (baseline, midline, and end line)
Assessment of vitamin A status
5 secondary outcomes
Height-for-age change
Time frame: 0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-age change
Time frame: 0, 10, 20 weeks (baseline, midline, and end line)
Weight-for-height change
Time frame: 0, 10, 20 weeks (baseline, midline, and end line)
Moderate malnutrition status change
Time frame: 0, 10, 20 weeks (baseline, midline, and end line)
Mid-upper arm circumference change
Time frame: 0, 10, 20 weeks (baseline, midline, and end line)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Derived from this study: PubMed 31143849Delimont 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.
- Derived from this study: PubMed 29955700Delimont 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Corn Soy Blend Plus (CSB+), Corn Soy Blend 14 (CSB14) and White Sorghum Cowpea Blend Variety 1 in people with Anemia, Iron-Deficiency and Deficiency, Vitamin A, run by Kansas State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin Change (time frame: 0, 10, 20 weeks (baseline, midline, and end line)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847962, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.