Back to resultsIron Fish for Dominican Republic (DR) Infants
Primary Purpose
Iron-deficiency, Iron Deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
Dominican Republic
Study Type
Interventional
Intervention
Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement
Sponsored by
About this trial
This is an interventional prevention trial for Iron-deficiency focused on measuring Iron-deficiency, Iron Deficiency Anemia
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
Sites / Locations
- Ninos Primeros en Salud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lucky Iron Fish™ (LIF)
Enhanced standard of care (eSOC)
Arm Description
For Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one ~ 200g iron ingot.
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).
Outcomes
Primary Outcome Measures
Change in hemoglobin over time
Investigators will assess changes in hemoglobin within each study arm and compare hemolgobin levels between study arms (intervention vs. standard of care). Hemoglobin will be measured in grams per deciliter (g/dL) and measured at 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.
Secondary Outcome Measures
Rates of refusal
Rates of refusal to participate in study measured as proportion of subjects refusing to enter study compared to total number approached.
Retention
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.
Adherence to iron ingot use
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.
Difference in microbiomes and microbiota
Using results from rectal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC
Difference in microbiomes and microbiota
Using results from nasopharyngeal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC
Full Information
NCT ID
NCT03606993
First Posted
July 10, 2018
Last Updated
January 30, 2020
Sponsor
Children's Hospital of Philadelphia
Collaborators
Lucky Iron Fish
1. Study Identification
Unique Protocol Identification Number
NCT03606993
Brief Title
Iron Fish for Dominican Republic (DR) Infants
Official Title
Cooking With Iron Ingots: Assessing Feasibility and Natural History Among Infants in Resource-limited Settings
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
January 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Lucky Iron Fish
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia
Keywords
Iron-deficiency, Iron Deficiency Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lucky Iron Fish™ (LIF)
Arm Type
Experimental
Arm Description
For Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one ~ 200g iron ingot.
Arm Title
Enhanced standard of care (eSOC)
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in hemoglobin over time
Description
Investigators will assess changes in hemoglobin within each study arm and compare hemolgobin levels between study arms (intervention vs. standard of care). Hemoglobin will be measured in grams per deciliter (g/dL) and measured at 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.
Time Frame
6-months and 12-months
Secondary Outcome Measure Information:
Title
Rates of refusal
Description
Rates of refusal to participate in study measured as proportion of subjects refusing to enter study compared to total number approached.
Time Frame
12-months
Title
Retention
Description
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.
Time Frame
12-months
Title
Adherence to iron ingot use
Description
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.
Time Frame
12-months
Title
Difference in microbiomes and microbiota
Description
Using results from rectal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC
Time Frame
12-months
Title
Difference in microbiomes and microbiota
Description
Using results from nasopharyngeal swabs, the study will compare the microbiome and microbiota of infants receiving LIF+citus vs. eSOC
Time Frame
12-months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Lowenthal, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ninos Primeros en Salud
City
Consuelo
State/Province
San Pedro De Macoris
Country
Dominican Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29221528
Citation
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.
Results Reference
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Iron Fish for Dominican Republic (DR) Infants
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