Clinical Trials Logo

Clinical Trial Summary

The overall hypotheses is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches. The objectives of this study will be 1) to assess the nutritional adequacy of Kenyan households with children and 2) to determine the market potential of a locally sourced and manufactured, blended fortified, cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months. This study will simulate a market study, the investigators conducted a product launch, determined market potential based on sales, evaluated marketing strategy to increase market share, and modeled the nutritional contribution of FtFF/traditionally fortified product for iron, zinc, and vitamin A. The investigators expect to provide a throughout evaluation of a business-driven strategy (for profit, social enterprise) as a sustainable tool to decrease micronutrient deficiencies.


Clinical Trial Description

Basic design: Participants will be approached/recruited by research assistants on the ground at designated local markets. Potential participants will be consented if they agree to join the study at the time of recruitment. While attendance is not required by participants, product demonstrations will be conducted at the study sites, similar to a grocery store demonstration, to show how the instant flour is reconstituted. At the same time, consumers who are attending the demonstrations may be asked if they would participate in the study. Research assistants will read the consent form to the participants and ensure they understand it. Purdue investigator(s) (one or more - Torres-Aguilar, Rendall, Hamaker) will be present in Eldoret at all study phases involving consenting and data collection. Products will be produced, distributed on a weekly basis to sites. The investigators plan on introducing the "new" product to consumers at random at in-store displays at individual locations for 2 weeks, and then continue to promote (advertise) and sell the placed product for a period of 8 weeks. The following schedules are proposed: Weeks 1-2: Product demonstrations and sampling for consumers Weeks 3-5: Product sold at below market cost of other cereal flour products (as part of active promotion) Weeks 6-10: At one half of the locations, product sold at parity to other cereal products (with advertising but no additional promotion, i.e. discounts). Data to be collected both from store managers and individual consumers. Enumerators will be trained and placed at each sales' location in the morning and evening to coincide with peak shopping times. They will be tasked with collecting a random sample of consumers who are purchasing cereals (1,200 total over 10 weeks). In this sample, both purchasers and non-purchasers of the FtFF fortified products will be identified and consented. Phone numbers will be collected and a follow up appointment/interview scheduled with half of them (600). Enumerators will also coordinate the collection of data from point of sale managers: 1. Total volume/units of FtFF fortified product sold 2. Total volume/units cereal products sold 3. Total value of FtFF fortified product sold 4. TotaI value of cereal product sold 5. Product comments from consumers (include any returns or complaints) 6. Number of repeat purchasers Follow up interviews with consumers will be conducted at a private location close to the centralized market sites or points of original purchase within 2 weeks. This is to enable follow up without inconveniencing participant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05882682
Study type Observational [Patient Registry]
Source Purdue University
Contact
Status Completed
Phase
Start date October 20, 2022
Completion date December 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT04949165 - Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study N/A
Terminated NCT03218384 - Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency Phase 2
Active, not recruiting NCT03516734 - Iron-fortified Lentils to Improve Iron (Fe) Status in Bangladesh N/A
Completed NCT03572010 - Stable Iron Isotope Method in HIV+ and HIV- Children N/A
Active, not recruiting NCT03703726 - Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures. N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Not yet recruiting NCT05395468 - Diagnosis of Iron Deficiency by Artificial Intelligence Analysis of Eye Photography.
Withdrawn NCT03800446 - Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood N/A
Not yet recruiting NCT03353662 - Sub Regional Micronutrient Survey in Ethiopia
Completed NCT03819530 - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study N/A
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT03957057 - Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia Phase 3
Completed NCT03642223 - Central and Peripheral Adiposity and Iron Absorption N/A
Not yet recruiting NCT05407987 - Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) Phase 3
Withdrawn NCT03873584 - Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Completed NCT04359368 - Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Enrolling by invitation NCT05750940 - Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
Recruiting NCT05126901 - Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years Phase 3