Iron Fish for Dominican Republic (DR) Infants

NCT ID: NCT03606993

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2020-01-17

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.

Conditions

Iron-deficiency; Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Lucky Iron Fish™ (LIF)

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lucky Iron Fish

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Lowenthal, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Ninos Primeros en Salud

Consuelo, San Pedro de Macorís, Dominican Republic

Countries

Dominican Republic

References

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.

Reference Type: BACKGROUND

PMID: 29221528 (View on PubMed)

Other Identifiers

16-012988

Identifier Type: -

Identifier Source: org_study_id