Iron Fish for Dominican Republic (DR) Infants

Not Applicable

Completed

• Conditions: Iron-deficiency; Iron Deficiency Anemia
• Interventions: Other: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement

• Registration Number: NCT03606993
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-31
• Study Start: 2018-08-13
• Status Verified: 2020-01
• Primary Completion: 2020-01-17
• Study Completion: 2020-01-17
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lucky Iron Fish™ (LIF)	Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement	For Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one \~ 200g iron ingot.

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin over time	6-months and 12-months	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.

Secondary Outcome Measures

Name	Time	Method
Retention	12-months	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.
Adherence to iron ingot use	12-months	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.
Rates of refusal	12-months	Rates of refusal to participate in study measured as proportion of subjects refusing to enter study compared to total number approached.
Difference in microbiomes and microbiota	12-months	Using results from nasopharyngeal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC

Trial Locations

Locations (1)

Ninos Primeros en Salud; 🇩🇴 Consuelo, San Pedro De Macoris, Dominican Republic