Lucky Iron Fish Home Fortification of Iron

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Iron Fish for Dominican Republic (DR) Infants

NCT03606993

Iron-deficiency Iron Deficiency Anemia

COMPLETED NA

Potential Harms of Untargeted Iron Supplementation in Cambodia Where Iron Deficiency is Not the Cause of Anemia

NCT04017598

Anemia, Iron Deficiency Anemia Intestinal Inflammation +2 more

COMPLETED PHASE4

Efficacy of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia

NCT02257762

Child Malnutrition

UNKNOWN NA

Acceptability of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia

NCT02257437

Child Malnutrition

COMPLETED NA

Is Iron Deficiency the Cause of Anemia Among Women in Cambodia?

NCT02481375

Anemia Iron Deficiency Hemoglobin Disorder +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia Anemia, Iron-Deficiency Hemoglobinopathies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lucky Iron Fish

This group will receive a Lucky Iron Fish to use during cooking.

Group Type EXPERIMENTAL

Lucky Iron Fish - home fortification system

Intervention Type OTHER

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.

18 mg iron

This group will receive a daily oral iron supplement.

Group Type ACTIVE_COMPARATOR

18 mg elemental iron

Intervention Type DIETARY_SUPPLEMENT

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).

Control group

This group will receive nutrition education

Group Type OTHER

Nutrition Education

Intervention Type OTHER

This group will receive education containing key messages around anemia, malaria, iron intake, and dietary diversity.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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).

Intervention Type DIETARY_SUPPLEMENT

Nutrition Education

This group will receive education containing key messages around anemia, malaria, iron intake, and dietary diversity.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No