Lucky Iron Fish Home Fortification of Iron

NCT02341586 | Completed

• 1 other identifier: H14-02551
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Anemia, Iron-Deficiency; Hemoglobinopathies

Keywords

Malaria; Cambodia; Iron; Childbearing Age; Women; Home Fortification

Outcome Measures

Primary Outcomes (1)

• hemoglobin concentration at endline

  12 months

Secondary Outcomes (4)

• Change in ferritin concentration

  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

  Baseline (t=0), midline (t=6 months), and endline (t=12 months)

Study Arms (3)

Lucky Iron Fish

EXPERIMENTAL

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

Other: Lucky Iron Fish - home fortification system

18 mg iron

ACTIVE COMPARATOR

This group will receive a daily oral iron supplement.

Dietary Supplement: 18 mg elemental iron

Control group

OTHER

This group will receive nutrition education

Other: Nutrition Education

Interventions

Lucky Iron Fish - home fortification system 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.

Lucky Iron Fish

18 mg elemental iron 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).

18 mg iron

Nutrition Education OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• NCHADS - Ministry of Health of Cambodia: collaborator
• University of Guelph: collaborator

Study Sites (1)

Rovieng Health Centre

Rovieng Tboung, Preah Vihear, Cambodia

Location

Related Publications (1)

• 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.

  PMID: 28615257 DERIVED

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Hemoglobinopathies; Malaria

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Tim J Green, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 19, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)