Anemia Clinical Trial
Official title:
A Randomized Control Trial of the Lucky Iron Fish to Improve Hemoglobin Concentration in Women in Preah Vihear, Cambodia
Verified date | March 2018 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 340 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Cambodia | Rovieng Health Centre | Rovieng | Preah Vihear |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | NCHADS - Ministry of Health of Cambodia, University of Guelph |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hemoglobin concentration at endline | 12 months | ||
Secondary | 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) | |
Secondary | Number of women in Preah Vihear, Cambodia with a genetic hemoglobin disorder | Midline (t=6 months) | ||
Secondary | 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) | ||
Secondary | 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) |
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