Iron Fish for Dominican Republic (DR) Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Iron-deficiency, Iron Deficiency Anemia

Intervention / Treatment
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* Other: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucky Iron Fish™ (LIF)<br>For Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one   200g iron ingot. | Other: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement<br>* 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.<br>|
| No Intervention: Enhanced standard of care (eSOC)<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin over time | Investigators will assess changes in hemoglobin within each study arm and compare hemolgobin levels between study arms (intervention vs. standard of care). Hemoglobin will be measured in grams per deciliter (g/dL) and measured at 6-months, and 12-months. If data is normally distributed, a paired/dependent t-test will be used, if non-normal, a non-parametric test like Wilcoxon's Matched pairs test will be used. | 6-months and 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of refusal | Rates of refusal to participate in study measured as proportion of subjects refusing to enter study compared to total number approached. | 12-months | 
| Retention | Within each study arm (Iron ingot vs. Oral iron supplementation), will calculate proportion lost to follow-up. Number of subjects lost to follow up divided total number of subjects enrolled at study entry. | 12-months | 
| Adherence to iron ingot use | Using a questionnaire with several likert-scale questions, we will assess adherence to iron ingot use. Questions include When was the last time you used the Fish, how often do you use the fish for meal preparation, how often do you use the fish to prepare water, how long do you typically boil the fish. The answer to each question has between 4-5 possible ordinal responses which will be converted into numerical data (1,2,3,4,5) and cumulative scores will be created to assess degree of use/adherence. | 12-months | 
| Difference in microbiomes and microbiota | Using results from rectal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC | 12-months | 
| Difference in microbiomes and microbiota | Using results from nasopharyngeal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron-deficiency, Iron Deficiency Anemia