Clinical trial NCT02341586: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Anemia, Iron-Deficiency
Hemoglobinopathies
Keywords: Malaria
Cambodia
Iron
Childbearing Age
Women
Home Fortification
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: NCHADS - Ministry of Health of Cambodia
name: University of Guelph
First posted: 2015-01-19
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: hemoglobin concentration at endline
timeFrame: 12 months
Secondary outcomes:
measure: Change in ferritin concentration
timeFrame: Baseline (t=0), midline (t=6 months), and endline (t=12 months)
measure: Number of women in Preah Vihear, Cambodia with a genetic hemoglobin disorder
timeFrame: Midline (t=6 months)
measure: How the prevalence of malaria changes in women living in Preah Vihear Cambodia over one year
timeFrame: Baseline (t=0), midline (t=6 months), and endline (t=12 months)
measure: Change in soluble transferrin receptor (sTfR) concentration
timeFrame: Baseline (t=0), midline (t=6 months), and endline (t=12 months)
Other outcomes:
Locations:
city: Rovieng
country: Cambodia
facility: Rovieng Health Centre
state: Preah Vihear
Study officials:
affiliation: University of British Columbia
name: Tim J Green, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.