Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia
NCT ID: NCT01380548
Last Updated: 2013-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2011-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Placebo
Placebo; once/day; for 12 weeks
Iron alone
Iron alone
Iron (3 mg); once/day; for 12 weeks
Low-dose 5-aminolevulinic acid
Low-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks
Medium-dose 5-aminolevulinic acid
Medium-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks
High-dose 5-aminolevulinic acid
High-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks
Interventions
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Placebo
Placebo; once/day; for 12 weeks
Iron alone
Iron (3 mg); once/day; for 12 weeks
Low-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks
Medium-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks
High-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Willing not to donate blood during the study
* Informed consent signed
Exclusion Criteria
* 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
20 Years
49 Years
FEMALE
No
Sponsors
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SBI ALApromo Co., Ltd., Japan
UNKNOWN
Hiroshima University
OTHER
Responsible Party
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Fumiko Higashikawa
Associate Professor
Locations
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Hiroshima University
Hiroshima, , Japan
Countries
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Other Identifiers
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eki-396
Identifier Type: -
Identifier Source: org_study_id
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