Iron Fish in Dominican Republic (DR) Children

NCT ID: NCT03199235

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2018-10-16

Brief Summary

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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Detailed 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

Conditions

Iron Deficiency Anemia; Anemia; Iron-deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

LIF + Citrus

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.

Group Type: EXPERIMENTAL

Lucky Iron Fish

Intervention Type: DEVICE

200g iron ingot that is placed in boiling water for 10+ minutes, and then removed. The water is then used to eating and drinking.

enhanced standard of care

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.

Group Type: ACTIVE_COMPARATOR

enhanced standard of care

Intervention Type: OTHER

parents of subjects are provided oral iron supplementation per usual clinical care at clinic and followed for their anemia in addition to study visits

Interventions

Lucky Iron Fish

200g iron ingot that is placed in boiling water for 10+ minutes, and then removed. The water is then used to eating and drinking.

Intervention Type: DEVICE

enhanced standard of care

parents of subjects are provided oral iron supplementation per usual clinical care at clinic and followed for their anemia in addition to study visits

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• 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

Locations

Ninos Primeros en Salud

Consuelo, San Pedro de Macorís, Dominican Republic

Countries

Dominican Republic

Other Identifiers

16-012631

Identifier Type: -

Identifier Source: org_study_id