Iron-deficiencyNCT03606993
Iron Fish for Dominican Republic (DR) Infants
A study testing Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement in people with Iron-deficiency and Iron Deficiency Anemia, run by Children's Hospital of Philadelphia at 1 site in Dominican Republic.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia
- What is being tested?
- Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDominican Republic
- Study dates
- 13 Aug 2018to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Ninos Primeros en Salud
Consuelo, San Pedro de Macorís
About this study
Official title: Cooking With Iron Ingots: Assessing Feasibility and Natural History Among Infants in Resource-limited Settings
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.
Read the 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.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Being tested
- Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement
- Keywords
- Iron-deficiency, Iron Deficiency Anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lucky Iron Fish™ (LIF) | Experimental | For Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one ~ 200g iron ingot. Receives: Other: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement |
| Enhanced standard of care (eSOC) | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months and 12-months
Secondary outcomes (5)
Rates of refusal
Rates of refusal to participate in study measured as proportion of subjects refusing to enter study compared to total number approached.
Measured: 12-months
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.
Measured: 12-months
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.
Measured: 12-months
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
Measured: 12-months
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
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start13 Aug 2018
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Lucky Iron Fish
- Responsible party
- Sponsor
- Investigators
- Elizabeth Lowenthal, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606993
- Sponsor's protocol ID
- 16-012988
- Status last verified
- Jan 2020
- First submitted
- 10 Jul 2018
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29221528
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooking With Iron Ingots: Assessing Feasibility and Natural History Among Infants in Resource-limited Settings
- ClinicalTrials.gov ID
- NCT03606993
- Acronym / sponsor ID
- 16-012988
- Conditions
- Iron-deficiency, Iron Deficiency Anemia
- Keywords
- Iron-deficiency, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Lucky Iron Fish
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lucky Iron Fish™ (LIF) | Experimental | Other: Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplementFor Mother-infant dyads enrolled into the LIF arm, mother receives a cooking supplement: one ~ 200g iron ingot. |
| Enhanced standard of care (eSOC) | No intervention | –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). |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplementFor 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. | Other | Lucky Iron Fish™ (LIF) |
Primary outcome
Change in hemoglobin over time
Time frame: 6-months and 12-months
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.
5 secondary outcomes
Rates of refusal
Time frame: 12-months
Retention
Time frame: 12-months
Adherence to iron ingot use
Time frame: 12-months
Difference in microbiomes and microbiota
Time frame: 12-months
Difference in microbiomes and microbiota
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Background: PubMed 29221528McKee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Lowenthal, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement in people with Iron-deficiency and Iron Deficiency Anemia, run by Children's Hospital of Philadelphia at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin over time (time frame: 6-months and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.