Iron Deficiency AnemiaNCT03199235
Iron Fish in Dominican Republic (DR) Children
A study testing Lucky Iron Fish in people with Iron Deficiency Anemia and Anemia, run by Children's Hospital of Philadelphia at 1 site in Dominican Republic.
Trial 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. . Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia, Anemia, Iron-deficiency
- What is being tested?
- Lucky Iron Fish
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDominican Republic
- Study dates
- 20 Feb 2017to 16 Oct 2018
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
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 of Iron-deficiency Anemia Among Preschool-aged Children in Resource-limited Settings
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.
.
Read the 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
- Being tested
- Lucky Iron Fish, enhanced standard of care
- Keywords
- iron intake, iron bioavailability
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucky Iron FishDevice
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 careOther
parents of subjects are provided oral iron supplementation per usual clinical care at clinic and followed for their anemia in addition to study visits
| Study group | Role | What they receive |
|---|---|---|
| LIF + Citrus | Experimental | 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. Receives: Device: Lucky Iron Fish |
| enhanced standard of care | Active comparator | 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. Receives: Other: enhanced standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Adherence to oral iron use
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.
Measured: 12-months
Natural history of hemoglobin among those subjects using iron ingot
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.
Measured: 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
Natural history of hemoglobin among those subjects using oral iron
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.
Measured: 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
Natural history hemoglobin: Iron ingot vs. Oral iron
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).
Measured: 12-month.
Secondary outcomes (3)
Natural history of serum ferritin among subjects using iron ingot
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.
Measured: 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
Natural history of serum ferritin among subjects using oral iron
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.
Measured: 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
Natural history serum ferritin: Iron ingot vs. Oral iron
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).
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 posted26 Jun 2017
- Study start20 Feb 2017
- Primary completion16 Oct 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199235
- Sponsor's protocol ID
- 16-012631
- Status last verified
- Nov 2018
- First submitted
- 7 Jun 2017
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooking With Iron Ingots: Assessing Feasibility and Natural History of Iron-deficiency Anemia Among Preschool-aged Children in Resource-limited Settings
- ClinicalTrials.gov ID
- NCT03199235
- Acronym / sponsor ID
- 16-012631
- Conditions
- Iron Deficiency Anemia, Anemia, Iron-deficiency
- Keywords
- iron intake, iron bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Lucky Iron Fish
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 26 Jun 2017 (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.
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.
.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIF + Citrus | Experimental | Device: Lucky Iron FishParents 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. |
| enhanced standard of care | Active comparator | Other: enhanced standard of careParents 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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 Fish200g iron ingot that is placed in boiling water for 10+ minutes, and then removed. The water is then used to eating and drinking. | Device | LIF + Citrus |
| enhanced standard of careparents of subjects are provided oral iron supplementation per usual clinical care at clinic and followed for their anemia in addition to study visits | Other | enhanced standard of care |
Primary outcome
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.
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.
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.
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.
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.
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.
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).
3 secondary outcomes
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
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
Natural history serum ferritin: Iron ingot vs. Oral iron
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 7 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Iron Deficiency Anemia and 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 6 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 7 Nov 2018. 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?
Rates of refusal (time frame: 12-months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2018.