Clinical trial NCT03199235: Iron Fish in Dominican Republic (DR) Children
Official title: Cooking With Iron Ingots: Assessing Feasibility and Natural History of Iron-deficiency Anemia Among Preschool-aged Children in Resource-limited Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Anemia
Iron-deficiency
Keywords: iron intake
iron bioavailability
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Lucky Iron Fish
First posted: 2017-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Rates of refusal
timeFrame: 12-months
measure: Retention
timeFrame: 12-months
measure: Adherence to iron ingot use
timeFrame: 12-months
measure: Adherence to oral iron use
timeFrame: 12-months
measure: Natural history of hemoglobin among those subjects using iron ingot
timeFrame: Will be at 4 individual points over a 12-mo period - at enrollment, 3-month follow-up, 6-month follow-up, and 12-month follow-up which is study end. Thus, the time frame is 4 separate visits over a 12-month period
measure: Natural history of hemoglobin among those subjects using oral iron
timeFrame: Will be at 4 individual points over a 12-mo period - at enrollment, 3-month follow-up, 6-month follow-up, and 12-month follow-up which is study end. Thus, the time frame is 4 separate visits over a 12-month period
measure: Natural history hemoglobin: Iron ingot vs. Oral iron
timeFrame: 12-month.
Secondary outcomes:
measure: Natural history of serum ferritin among subjects using iron ingot
timeFrame: Will be at 4 individual points over a 12-mo period - at enrollment, 3-month follow-up, 6-month follow-up, and 12-month follow-up which is study end. Thus, the time frame is 4 separate visits over a 12-month period
measure: Natural history of serum ferritin among subjects using oral iron
timeFrame: Will be at 4 individual points over a 12-mo period - at enrollment, 3-month follow-up, 6-month follow-up, and 12-month follow-up which is study end. Thus, the time frame is 4 separate visits over a 12-month period
measure: Natural history serum ferritin: Iron ingot vs. Oral iron
timeFrame: 12-months
Other outcomes:
Locations:
city: Consuelo
country: Dominican Republic
facility: Ninos Primeros en Salud
state: San Pedro De Macoris
Study officials:
References: