NCT03606993

Iron Fish for Dominican Republic (DR) Infants

Cooking With Iron Ingots: Assessing Feasibility and Natural History Among Infants in Resource-limited Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Accepted

Summary

This study evaluates the feasibility of cooking with an iron ingot, Lucky Iron Fish™ (LIF), and evaluate the natural history of hemoglobins and iron status among infants of families using this iron ingot in a population with a high prevalence of iron-deficiency anemia. Participants are mother-infant dyads, and are randomized to one of two arms: Lucky Iron Fish™or enhanced standard of care.

Detailed description

Iron deficiency and iron-deficiency anemia contribute significantly to global pediatric morbidity, predominantly affecting women and preschool aged children in resource-limited settings. Iron-deficiency in infancy has been linked to neurodevelopmental delay. Current methods of iron repletion and supplementation have proved inadequate. The Lucky Iron Fish™ is a iron ingot, the size of a small bar of soap, that is made of pure iron. When boiled, it releases bioavailable iron into water, which is then used for food preparation and/or drinking. Participants in the LIF arm are instructed to acidify the water with citrus juice (provided). All participants are followed at the same intervals to complete questionnaires and study-related labs.

Conditions

• Iron-deficiency
• Iron Deficiency Anemia

Interventions

Type	Name	Description
OTHER	Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement	For Mother-infant dyads enrolled into the LIF arm, mother receives one \~ 200g iron ingot, instructions on use: add 2-3 drops of lemon juice to one-liter of water, place iron ingot in water, bring to boil for 10 minutes, remove iron fish from water and then use that water for cooking or drinking.

Timeline

• Start date: 2018-08-13
• Primary completion: 2020-01-17
• Completion: 2020-01-17
• First posted: 2018-07-31
• Last updated: 2020-01-31

Locations

1 site across 1 country: Dominican Republic