Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

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

Sponsors

Lead Sponsor: Hiroshima University

Collaborator: SBI ALApromo Co., Ltd., Japan

Source Hiroshima University
Brief Summary

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

Overall Status Completed
Start Date June 2011
Completion Date December 2012
Primary Completion Date December 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin level Every 4 weeks (Overall 20 weeks)
Secondary Outcome
Measure 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
Enrollment 135
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: Placebo; once/day; for 12 weeks

Arm Group Label: Placebo

Intervention Type: Dietary Supplement

Intervention Name: Iron alone

Description: Iron (3 mg); once/day; for 12 weeks

Arm Group Label: Iron alone

Intervention Type: Dietary Supplement

Intervention Name: Low-dose 5-aminolevulinic acid with iron

Description: 5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks

Arm Group Label: Low-dose 5-aminolevulinic acid

Intervention Type: Dietary Supplement

Intervention Name: Medium-dose 5-aminolevulinic acid with iron

Description: 5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks

Arm Group Label: Medium-dose 5-aminolevulinic acid

Intervention Type: Dietary Supplement

Intervention Name: High-dose 5-aminolevulinic acid with iron

Description: 5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks

Arm Group Label: High-dose 5-aminolevulinic acid

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 20 Years

Maximum Age: 49 Years

Healthy Volunteers: No

Location
Facility: Hiroshima University
Location Countries

Japan

Verification Date

March 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hiroshima University

Investigator Full Name: Fumiko Higashikawa

Investigator Title: Associate Professor

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Placebo

Type: Placebo Comparator

Label: Iron alone

Type: Placebo Comparator

Label: Low-dose 5-aminolevulinic acid

Type: Experimental

Label: Medium-dose 5-aminolevulinic acid

Type: Experimental

Label: High-dose 5-aminolevulinic acid

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov