Iron Fish for Dominican Republic (DR) Infants

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606993
• Other study ID #: 16-012988
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: January 17, 2020

Study information

• Verified date: January 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron-deficiency

Intervention

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.

Locations

Country	Name	City	State
Dominican Republic	Ninos Primeros en Salud	Consuelo	San Pedro De Macoris

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Lucky Iron Fish

Country where clinical trial is conducted

Dominican Republic, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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