Iron Fish for Dominican Republic (DR) Infants

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Iron Deficiency Anemia; Iron-deficiency

Treatments: Other: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03606993

16-012988

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: Under 3 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Lucky Iron Fish™ (LIF)

Experimental group

Description:

For Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one \~ 200g iron ingot.

Treatment:

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

Enhanced standard of care (eSOC)

No Intervention group

Description:

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).