Clinical trial NCT03606993: Iron Fish for Dominican Republic (DR) Infants
Official title: Cooking With Iron Ingots: Assessing Feasibility and Natural History Among Infants in Resource-limited Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anemia
Keywords: Iron-deficiency
Iron Deficiency Anemia
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Lucky Iron Fish
First posted: 2018-07-31
Enrollment: 300
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in hemoglobin over time
timeFrame: 6-months and 12-months
Secondary outcomes:
measure: Rates of refusal
timeFrame: 12-months
measure: Retention
timeFrame: 12-months
measure: Adherence to iron ingot use
timeFrame: 12-months
measure: Difference in microbiomes and microbiota
timeFrame: 12-months
measure: Difference in microbiomes and microbiota
timeFrame: 12-months
Other outcomes:
Locations:
city: Consuelo
country: Dominican Republic
facility: Ninos Primeros en Salud
state: San Pedro De Macoris
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elizabeth Lowenthal, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.