Iron Fish for Dominican Republic (DR) Infants

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

Sponsors

Lead Sponsor: Children's Hospital of Philadelphia

Collaborator: Lucky Iron Fish

Source Children's Hospital of Philadelphia
Brief 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.

Overall Status Completed
Start Date 2018-08-13
Completion Date 2020-01-17
Primary Completion Date 2020-01-17
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in hemoglobin over time 6-months and 12-months
Secondary Outcome
Measure Time Frame
Rates of refusal 12-months
Retention 12-months
Adherence to iron ingot use 12-months
Difference in microbiomes and microbiota 12-months
Difference in microbiomes and microbiota 12-months
Enrollment 300
Condition
Intervention

Intervention Type: Other

Intervention Name: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement

Description: 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.

Arm Group Label: Lucky Iron Fish™ (LIF)

Eligibility

Criteria:

Inclusion Criteria: - Mother ≥ 18 years of age - A newborn delivered at ≥ 35 weeks - Infant Child followed by (or will be followed by) affiliated clinic (Niños Primeros en Salud [NPS]) OR Infant delivered at Angel Ponce, the local maternity hospital of Consuelo, Dominican Republic. - Mother is Spanish speaking - Mother permission is provided (informed consent) Exclusion Criteria: - Maternal history of Sickle Cell Disease (homozygous) - Concurrent enrollment in related study of LIF on anemia of young children (CHOP study #16-012631). - Inability to understand and speak Spanish - Severe cognitive impairment or severe psychiatric disease which would prohibit the answering of study questions

Gender:

All

Minimum Age:

N/A

Maximum Age:

3 Months

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Elizabeth Lowenthal, MD, MSCE Principal Investigator Children's Hospital of Philadelphia
Location
Facility: Ninos Primeros en Salud
Location Countries

Dominican Republic

Verification Date

2020-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Lucky Iron Fish™ (LIF)

Type: Experimental

Description: For Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one ~ 200g iron ingot.

Label: Enhanced standard of care (eSOC)

Type: No Intervention

Description: For mother-infant dyads in the eSOC arm, families are not provided iron supplementation (consistent with standard of care) but have additional visits and laboratory monitoring beyond well-child care (enhanced).

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

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