NCT03199235

Iron Fish in Dominican Republic (DR) Children

Cooking With Iron Ingots: Assessing Feasibility and Natural History of Iron-deficiency Anemia Among Preschool-aged Children in Resource-limited Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to assess the acceptability, feasibility, and barriers to Lucky Iron Fish™ (LIF) utilization among families with young children in a Latin American community with a high prevalence of iron deficiency and iron-deficiency anemia. .

Detailed description

The primary objective is to assess the acceptability of cooking with an iron ingot (Lucky Iron Fish™) compared to traditional oral iron supplementation methods among preschool aged children in a Dominican community with a high prevalence of anemia (\> 50%). Data will be collected to characterize the natural history of iron deficiency and anemia in pre-school aged children in a Dominican community. The study will involve a randomized control trial to assess the primary objective: children \> 1 year and \< 5 years of age will be randomized into two study arms: LIF plus citrus (LIF arm) versus standard iron-supplementation (enhanced standard of care). Participants enrolled in the both study arms will have study labs drawn every 3, 6, and 12-months (hemoglobin, serum ferritin, c-reactive protein) to assess the natural history of iron deficiency in these children. Concomitant to study labs, parents/guardians will be surveyed on acceptability, compliance, and barriers to use of their assigned iron supplementation method. Primary study outcomes are the change in hemoglobin within the LIF group and then difference in change in hemoglobin between study arms over a 12-month study period. Secondary outcomes include changes in serum ferritin within and between study arms and exploring the relationship between changes in hemoglobin, serum ferritin, and C-reactive protein

Conditions

• Iron Deficiency Anemia
• Anemia
• Iron-deficiency

Interventions

Type	Name	Description
DEVICE	Lucky Iron Fish	200g iron ingot that is placed in boiling water for 10+ minutes, and then removed. The water is then used to eating and drinking.
OTHER	enhanced standard of care	parents of subjects are provided oral iron supplementation per usual clinical care at clinic and followed for their anemia in addition to study visits

Timeline

• Start date: 2017-02-20
• Primary completion: 2018-10-16
• Completion: 2018-10-16
• First posted: 2017-06-26
• Last updated: 2018-11-07

Locations

1 site across 1 country: Dominican Republic