Lucky Iron Fish Home Fortification of Iron
Primary Purpose
Anemia, Anemia, Iron-Deficiency, Hemoglobinopathies
Status
Completed
Phase
Not Applicable
Locations
Cambodia
Study Type
Interventional
Intervention
Lucky Iron Fish - home fortification system
18 mg elemental iron
Nutrition Education
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring Malaria, Cambodia, Iron, Childbearing Age, Women, Home Fortification
Eligibility Criteria
Inclusion Criteria:
- Mild or Moderate Anemia [Hb 80-119]
- Willing to provide a fingerprick sample of blood at baseline
- Willing to provide 10 mL of venous blood at 0, 6 & 12 months
- Not planning on moving in the next 12 months
- Not participating in any other nutrition intervention
- Be able to provide written and information consent
Exclusion Criteria:
- Be ill or taking any medications [Hb < 80]
- Have normal Hb status [Hb > 120]
- Currently consuming or planning to consume Fe supplements in the next 12 months
- Pregnant (based on self report)
Sites / Locations
- Rovieng Health Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Lucky Iron Fish
18 mg iron
Control group
Arm Description
This group will receive a Lucky Iron Fish to use during cooking.
This group will receive a daily oral iron supplement.
This group will receive nutrition education
Outcomes
Primary Outcome Measures
hemoglobin concentration at endline
Secondary Outcome Measures
Change in ferritin concentration
Ferritin is a biomarker of iron status. Ferritin will be corrected with measures using measures of alpha-1 acid glycoprotein and C-reactive protein.
Number of women in Preah Vihear, Cambodia with a genetic hemoglobin disorder
How the prevalence of malaria changes in women living in Preah Vihear Cambodia over one year
Change in soluble transferrin receptor (sTfR) concentration
sTfR is a biomarker of iron status
Full Information
NCT ID
NCT02341586
First Posted
January 9, 2015
Last Updated
March 14, 2018
Sponsor
University of British Columbia
Collaborators
NCHADS - Ministry of Health of Cambodia, University of Guelph
1. Study Identification
Unique Protocol Identification Number
NCT02341586
Brief Title
Lucky Iron Fish Home Fortification of Iron
Official Title
A Randomized Control Trial of the Lucky Iron Fish to Improve Hemoglobin Concentration in Women in Preah Vihear, Cambodia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
NCHADS - Ministry of Health of Cambodia, University of Guelph
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to determine if cooking with an iron ingot called the Lucky Iron Fish (LIF) increases the hemoglobin status in women of childbearing age living in Preah Vihear, Cambodia. The investigators hypothesize that the use of the LIF during cooking over a 12-month period will be as efficacious at increasing hemoglobin concentration as iron supplements (18 mg elemental iron) and will be more efficacious than the control.
Detailed Description
Background: Anemia is prevalent in Cambodia, affecting ~44% of women. The causes of anemia are multifactorial. Globally, the most common form is iron deficiency anemia (IDA), which can lead to adverse perinatal health outcomes. In Cambodia, there is evidence that suggests hemoglobinopathies (genetic hemoglobin [Hb] disorders) are prevalent (~50%) and are a major contributor to anemia. In Preah Vihear province, Cambodia, the estimated prevalence of malaria is ~12.3%. Malaria contributes to anemia through a decrease in the production of red blood cells, and an increased destruction of red blood cells.
In Cambodia, iron supplements are recommended to treat anemia, however there is evidence of low compliance among women. The use of cast iron pots has proven to be an effective alternative to prevent and reduce IDA in developing countries. However, cast iron pots are not commonly used in Cambodia because they are expensive, difficult to clean, and heavy. A novel alternative is the Lucky Iron Fish (LIF), which is an iron ingot used during cooking as an in-home fortification system of iron transfer. The LIF ingot is small, lightweight, and easy to clean. Previous research in Cambodia confirmed the acceptance of the LIF to be high, but findings from this study were inconclusive and had several limitations.
Objective: The primary objective of this study is to determine the efficacy of the LIF to increase Hb concentration in Cambodian women of reproductive age.
Methods: A total of 330 women (18-49 y) with mild or moderate anemia (Hb 80-120 g/L) from rural Preah Vihear, Cambodia will be recruited to one of three arms to receive LIF, 18 mg elemental iron, or a placebo. Women with severe anemia will be excluded and referred for treatment. All three groups will receive nutrition education. Monitoring will be conducted monthly to measure compliance.
A trained, Khmer-speaking interviewer will meet with the women to explain the details of the study as per the consent form. Once consent is obtained the trained interviewer will measure hemoglobin status using a hemocue device to confirm eligibility of the study. If eligible, the trained interviewer will then administer the baseline questionnaire in the participant's home.
The questionnaire will collect demographic data, as well as information on current dietary intake, drinking water treatment, knowledge of iron deficiency anemia, knowledge of malaria, and perceptions of supplement use.
Participants will have a venous blood sample taken at 0, 6, and 12 months and analyzed for hemoglobin and multiple biomarkers of iron status (e.g. soluble transferrin receptor, ferritin, and retinol binding protein (RBP)). Ferritin will be corrected for inflammation using measures of alpha-1 acid glycoprotein (AGP, g/L) and C-reactive protein (CRP, mg/L) which are biomarkers of chronic and acute inflammation, respectively.
Genotyping will be conducted to determine the prevalence of hemoglobinopathies among women. The prevalence of malaria in this cohort will be determined using rapid diagnostic test kits for P. Falciparum, and P. Vivax at baseline, midline, and endline.
Potential Significance: The LIF has the potential to be a low cost, effective and simple-to-use product to prevent and reduce iron deficiency anemia in Cambodia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Anemia, Iron-Deficiency, Hemoglobinopathies
Keywords
Malaria, Cambodia, Iron, Childbearing Age, Women, Home Fortification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lucky Iron Fish
Arm Type
Experimental
Arm Description
This group will receive a Lucky Iron Fish to use during cooking.
Arm Title
18 mg iron
Arm Type
Active Comparator
Arm Description
This group will receive a daily oral iron supplement.
Arm Title
Control group
Arm Type
Other
Arm Description
This group will receive nutrition education
Intervention Type
Other
Intervention Name(s)
Lucky Iron Fish - home fortification system
Intervention Description
The Lucky Iron Fish (LIF) is an ingot used during cooking as an in-home fortification system of iron. The LIF works on the same principle as cast iron pots and pans by increasing dietary intake of iron but is small and lightweight. The LIF was designed in collaboration with village elders and community members to ensure it would be accepted in Cambodia. The iron ingot resembles a local fish believed to be lucky among villages in Cambodia, contributing to the acceptability of the ingot.
Intervention Type
Dietary Supplement
Intervention Name(s)
18 mg elemental iron
Intervention Description
This dose of iron is the recommend dietary allowance (RDA) for iron for this cohort. Women will receive one-on-one instructions on how best to consume their tablet (for example, with food).
Intervention Type
Other
Intervention Name(s)
Nutrition Education
Intervention Description
This group will receive education containing key messages around anemia, malaria, iron intake, and dietary diversity.
Primary Outcome Measure Information:
Title
hemoglobin concentration at endline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in ferritin concentration
Description
Ferritin is a biomarker of iron status. Ferritin will be corrected with measures using measures of alpha-1 acid glycoprotein and C-reactive protein.
Time Frame
Baseline (t=0), midline (t=6 months), and endline (t=12 months)
Title
Number of women in Preah Vihear, Cambodia with a genetic hemoglobin disorder
Time Frame
Midline (t=6 months)
Title
How the prevalence of malaria changes in women living in Preah Vihear Cambodia over one year
Time Frame
Baseline (t=0), midline (t=6 months), and endline (t=12 months)
Title
Change in soluble transferrin receptor (sTfR) concentration
Description
sTfR is a biomarker of iron status
Time Frame
Baseline (t=0), midline (t=6 months), and endline (t=12 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild or Moderate Anemia [Hb 80-119]
Willing to provide a fingerprick sample of blood at baseline
Willing to provide 10 mL of venous blood at 0, 6 & 12 months
Not planning on moving in the next 12 months
Not participating in any other nutrition intervention
Be able to provide written and information consent
Exclusion Criteria:
Be ill or taking any medications [Hb < 80]
Have normal Hb status [Hb > 120]
Currently consuming or planning to consume Fe supplements in the next 12 months
Pregnant (based on self report)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim J Green, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rovieng Health Centre
City
Rovieng
State/Province
Preah Vihear
Country
Cambodia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28615257
Citation
Rappaport AI, Whitfield KC, Chapman GE, Yada RY, Kheang KM, Louise J, Summerlee AJ, Armstrong GR, Green TJ. Randomized controlled trial assessing the efficacy of a reusable fish-shaped iron ingot to increase hemoglobin concentration in anemic, rural Cambodian women. Am J Clin Nutr. 2017 Aug;106(2):667-674. doi: 10.3945/ajcn.117.152785. Epub 2017 Jun 14.
Results Reference
derived
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Lucky Iron Fish Home Fortification of Iron
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