Lucky Iron Fish Home Fortification of Iron

A Randomized Control Trial of the Lucky Iron Fish to Improve Hemoglobin Concentration in Women in Preah Vihear, Cambodia

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.

Study Overview

• Status: Completed
• Conditions: Anemia, Iron-Deficiency; Anemia; Hemoglobinopathies
• Intervention / Treatment: Other: Lucky Iron Fish - home fortification system; Dietary supplement: 18 mg elemental iron; Other: Nutrition Education

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.

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cambodia
  • Preah Vihear
    • Rovieng, Preah Vihear, Cambodia
      • Rovieng Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lucky Iron Fish; This group will receive a Lucky Iron Fish to use during cooking.	Other: Lucky Iron Fish - home fortification system; 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.
Active Comparator: 18 mg iron; This group will receive a daily oral iron supplement.	Dietary supplement: 18 mg elemental iron; 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).
Other: Control group; This group will receive nutrition education	Other: Nutrition Education; This group will receive education containing key messages around anemia, malaria, iron intake, and dietary diversity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hemoglobin concentration at endline	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (t=0), midline (t=6 months), and endline (t=12 months)
Number of women in Preah Vihear, Cambodia with a genetic hemoglobin disorder		Midline (t=6 months)
How the prevalence of malaria changes in women living in Preah Vihear Cambodia over one year		Baseline (t=0), midline (t=6 months), and endline (t=12 months)
Change in soluble transferrin receptor (sTfR) concentration	sTfR is a biomarker of iron status	Baseline (t=0), midline (t=6 months), and endline (t=12 months)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: University of Guelph; NCHADS - Ministry of Health of Cambodia
• Investigators: Principal Investigator: Tim J Green, PhD, University of British Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Women; Malaria; Iron; Cambodia; Childbearing Age; Home Fortification
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Hemoglobinopathies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: H14-02551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes