Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

Study Overview
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Brief Summary
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This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.

Official Title
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A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Iron alone
* Dietary Supplement: Low-dose 5-aminolevulinic acid with iron
* Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron
* Dietary Supplement: High-dose 5-aminolevulinic acid with iron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo; once/day; for 12 weeks<br>|
| Placebo Comparator: Iron alone<br> | Dietary Supplement: Iron alone<br>* Iron (3 mg); once/day; for 12 weeks<br>|
| Experimental: Low-dose 5-aminolevulinic acid<br> | Dietary Supplement: Low-dose 5-aminolevulinic acid with iron<br>* 5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks<br>|
| Experimental: Medium-dose 5-aminolevulinic acid<br> | Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron<br>* 5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks<br>|
| Experimental: High-dose 5-aminolevulinic acid<br> | Dietary Supplement: High-dose 5-aminolevulinic acid with iron<br>* 5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level |  | Every 4 weeks (Overall 20 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Soluble transferrin receptor level |  | Week 0 (baseline) and Week 12 | 
| Hepcidin-25 level |  | Week 0 (baseline) and Week 12 |