Iron Fish in Dominican Republic (DR) Children

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Anemia; Iron Deficiency Anemia; Iron-deficiency

Treatments: Device: Lucky Iron Fish; Other: enhanced standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT03199235

16-012631

Details and patient eligibility

About

The objective of the study is to assess the acceptability, feasibility, and barriers to Lucky Iron Fish™ (LIF) utilization among families with young children in a Latin American community with a high prevalence of iron deficiency and iron-deficiency anemia.

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Full description

The primary objective is to assess the acceptability of cooking with an iron ingot (Lucky Iron Fish™) compared to traditional oral iron supplementation methods among preschool aged children in a Dominican community with a high prevalence of anemia (> 50%). Data will be collected to characterize the natural history of iron deficiency and anemia in pre-school aged children in a Dominican community. The study will involve a randomized control trial to assess the primary objective: children > 1 year and < 5 years of age will be randomized into two study arms: LIF plus citrus (LIF arm) versus standard iron-supplementation (enhanced standard of care). Participants enrolled in the both study arms will have study labs drawn every 3, 6, and 12-months (hemoglobin, serum ferritin, c-reactive protein) to assess the natural history of iron deficiency in these children. Concomitant to study labs, parents/guardians will be surveyed on acceptability, compliance, and barriers to use of their assigned iron supplementation method.

Primary study outcomes are the change in hemoglobin within the LIF group and then difference in change in hemoglobin between study arms over a 12-month study period. Secondary outcomes include changes in serum ferritin within and between study arms and exploring the relationship between changes in hemoglobin, serum ferritin, and C-reactive protein

Enrollment: 80 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parent/guardian ≥ 18 years of age
• Child > 1 year and < 5 years of age
• Child followed by Niños Primeros en Salud (NPS)
• Parent/guardian is Spanish speaking
• Parental/guardian permission is provided (informed consent)

Exclusion criteria

• Mother/Infant pairs enrolled in related protocol of this study
• Inability to understand and speak Spanish
• Severe cognitive impairment or severe psychiatric disease which would prohibit the answering of study questions
• Child followed by NPS malnutrition program
• Persons receiving pre-designed nutrient-fortified foods or participation in another nutrition program
• Child has documented sickle cell disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

LIF + Citrus

Experimental group

Description:

Parents of subjects \> 1 year and \< 5 years with anemia (Hemoglobin \< 11.0 g/dL) are provided the lucky iron fish and citrus along with instructions for use. Followed at regular intervals.

Treatment:

Device: Lucky Iron Fish

enhanced standard of care

Active Comparator group

Description:

Parents of subjects \> 1 year and \< 5 years with anemia (Hemoglobin \< 11.0 g/dL) are provided the oral iron supplementation consistent with standard of care, and then followed at regular intervals in addition to any care determined to be necessary by regular provider.

Treatment:

Other: enhanced standard of care