Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia
Not Applicable
Completed
- Conditions
- Iron Deficiency Anemia
- Registration Number
- NCT01380548
- Lead Sponsor
- Hiroshima University
- Brief Summary
This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 135
Inclusion Criteria
- Premenopausal women with hemoglobin ≥ 9.0 g/dl and ≤ 12.0 g/dl
- Willing not to donate blood during the study
- Informed consent signed
Exclusion Criteria
- History of porphyria, hemochromatosis, or viral hepatitis
- Anemia other than iron deficiency
- BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
- Pregnant or nursing a child
- Participation in any clinical trial within 90 days of the commencement of the trial
- Renal or hepatic dysfunction
- Heart disease
- Subjects who are taking medicines or functional food that may affect hemoglobin level
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hemoglobin level Every 4 weeks (Overall 20 weeks)
- Secondary Outcome Measures
Name Time Method Hepcidin-25 level Week 0 (baseline) and Week 12 Soluble transferrin receptor level Week 0 (baseline) and Week 12 Serum ferritin level Every 4 weeks (Overall 20 weeks) Transferrin level Every 4 weeks (Overall 20 weeks) MCV level Every 4 weeks (Overall 20 weeks) TIBC level Every 4 weeks (Overall 20 weeks) Reticulocyte level Every 4 weeks (Overall 20 weeks) Red blood cell level Every 4 weeks (Overall 20 weeks) Hematocrit level Every 4 weeks (Overall 20 weeks) Serum iron level Every 4 weeks (Overall 20 weeks)
Trial Locations
- Locations (1)
Hiroshima University
🇯🇵Hiroshima, Japan
Hiroshima University🇯🇵Hiroshima, Japan