Iron Fish for Dominican Republic (DR) Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Iron Deficiency Anemia
• Intervention / Treatment: Other: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • San Pedro De Macoris
    • Consuelo, San Pedro De Macoris, Dominican Republic
      • Ninos Primeros en Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lucky Iron Fish™ (LIF); 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; 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.
No Intervention: Enhanced standard of care (eSOC); 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?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Lucky Iron Fish
• Investigators: Principal Investigator: Elizabeth Lowenthal, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• McKee SG, Close R, Lowenthal E. Evaluation of Iron Deficiency Anemia in a Pediatric Clinic in the Dominican Republic. Ann Glob Health. 2017 May-Aug;83(3-4):550-556. doi: 10.1016/j.aogh.2017.07.004.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): January 17, 2020

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Iron Deficiency Anemia; Iron-deficiency
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: 16-012988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No