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Iron Fish in Dominican Republic (DR) Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199235
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Lucky Iron Fish
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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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Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Anemia Iron-deficiency Device: Lucky Iron Fish Other: enhanced standard of care Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Cooking With Iron Ingots: Assessing Feasibility and Natural History of Iron-deficiency Anemia Among Preschool-aged Children in Resource-limited Settings
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : October 16, 2018
Actual Study Completion Date : October 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: 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.
Device: 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.

Active Comparator: 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.
Other: 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




Primary Outcome Measures :
  1. Rates of refusal [ Time Frame: 12-months ]
    Rates of refusal to participate in study measured as proportion of subjects refusing to enter study compared to total number approached.

  2. Retention [ Time Frame: 12-months ]
    Within each study arm (Iron ingot vs. Oral iron supplementation), will calculate proportion lost to follow-up. Number of subjects lost to follow up divided total number of subjects enrolled at study entry.

  3. Adherence to iron ingot use [ Time Frame: 12-months ]
    Using a questionnaire with several likert-scale questions, we will assess adherence to iron ingot use. Questions include "When was the last time you used the Fish", "how often do you use the fish for meal preparation", "how often do you use the fish to prepare water", "how long do you typically boil the fish". The answer to each question has between 4-5 possible ordinal responses which will be converted into numerical data (1,2,3,4,5) and cumulative scores will be created to assess degree of use/adherence.

  4. Adherence to oral iron use [ Time Frame: 12-months ]
    Using a questionnaire with several likert-scale questions, we will assess adherence to oral iron supplementation. Questions include: "How many doses were missed each week", "Do you recall dose and frequency of oral iron you were prescribed", "If doses were missed, was this accidental, intentional, or both". The answer to each question has between 4-5 possible ordinal responses which will be converted into numerical data (1,2,3,4,5) and cumulative scores will be created to assess degree of use/adherence.

  5. Natural history of hemoglobin among those subjects using iron ingot [ Time Frame: 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 ]
    We will assess changes in hemoglobin WITHIN iron ingot study arm. Hemoglobin will be measured in grams per deciliter (g/dL) and measured at enrollment, 3-months, 6-months, and 12-months. If data is normally distributed, a paired/dependent t-test will be used, if non-normal, a non-parametric test like Wilcoxon's Matched pairs test will be used.

  6. Natural history of hemoglobin among those subjects using oral iron [ Time Frame: 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 ]
    We will assess changes in hemoglobin WITHIN oral iron study arm. Hemoglobin will be measured in grams per deciliter (g/dL) and measured at enrollment, 3-months, 6-months, and 12-months. If data is normally distributed, a paired/dependent t-test will be used, if non-normal, a non-parametric test like Wilcoxon's Matched pairs test will be used.

  7. Natural history hemoglobin: Iron ingot vs. Oral iron [ Time Frame: 12-month. ]
    The difference in change in hemoglobin (measure in g/dL) between the study study arms (iron ingot arm vs. oral iron supplementation arm) will be assessed using two-sample t-test (normal distribution) or Wilcoxon-rank-sum (non-normal distribution).


Secondary Outcome Measures :
  1. Natural history of serum ferritin among subjects using iron ingot [ Time Frame: 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 ]
    We will assess changes in serum ferritin WITHIN iron ingot study arm. Serum ferritin will be measured in nanograms per milliliter (ng/mL) and measured at enrollment, 3-months, 6-months, and 12-months. If data is normally distributed, a paired/dependent t-test will be used, if non-normal, a non-parametric test like Wilcoxon's Matched pairs test will be used.

  2. Natural history of serum ferritin among subjects using oral iron [ Time Frame: 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 ]
    We will assess changes in serum ferritin WITHIN oral iron supplementation study arm. Serum ferritin will be measured in nanograms per milliliter (ng/mL) and measured at enrollment, 3-months, 6-months, and 12-months. If data is normally distributed, a paired/dependent t-test will be used, if non-normal, a non-parametric test like Wilcoxon's Matched pairs test will be used.

  3. Natural history serum ferritin: Iron ingot vs. Oral iron [ Time Frame: 12-months ]
    The difference in change in serum ferritin (measured in ng/mL) between the study study arms (iron ingot arm vs. oral iron supplementation arm) will be assessed using two-sample t-test (normal distribution) or Wilcoxon-rank-sum (non-normal distribution).



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199235


Locations
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Dominican Republic
Ninos Primeros en Salud
Consuelo, San Pedro De Macoris, Dominican Republic
Sponsors and Collaborators
Children's Hospital of Philadelphia
Lucky Iron Fish

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03199235    
Other Study ID Numbers: 16-012631
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
iron intake
iron bioavailability
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs