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Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Iron alone
Low-dose 5-aminolevulinic acid with iron
Medium-dose 5-aminolevulinic acid with iron
High-dose 5-aminolevulinic acid with iron
Sponsored by
Hiroshima University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency Anemia

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hiroshima University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Iron alone

Low-dose 5-aminolevulinic acid

Medium-dose 5-aminolevulinic acid

High-dose 5-aminolevulinic acid

Arm Description

Outcomes

Primary Outcome Measures

Hemoglobin level

Secondary Outcome Measures

Serum ferritin level
Transferrin level
MCV level
TIBC level
Reticulocyte level
Red blood cell level
Hematocrit level
Serum iron level
Soluble transferrin receptor level
Hepcidin-25 level

Full Information

First Posted
June 21, 2011
Last Updated
March 26, 2013
Sponsor
Hiroshima University
Collaborators
SBI ALApromo Co., Ltd., Japan
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1. Study Identification

Unique Protocol Identification Number
NCT01380548
Brief Title
Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia
Official Title
A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima University
Collaborators
SBI ALApromo Co., Ltd., Japan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Iron alone
Arm Type
Placebo Comparator
Arm Title
Low-dose 5-aminolevulinic acid
Arm Type
Experimental
Arm Title
Medium-dose 5-aminolevulinic acid
Arm Type
Experimental
Arm Title
High-dose 5-aminolevulinic acid
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo; once/day; for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron alone
Intervention Description
Iron (3 mg); once/day; for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-dose 5-aminolevulinic acid with iron
Intervention Description
5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Medium-dose 5-aminolevulinic acid with iron
Intervention Description
5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
High-dose 5-aminolevulinic acid with iron
Intervention Description
5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks
Primary Outcome Measure Information:
Title
Hemoglobin level
Time Frame
Every 4 weeks (Overall 20 weeks)
Secondary Outcome Measure Information:
Title
Serum ferritin level
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
Transferrin level
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
MCV level
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
TIBC level
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
Reticulocyte level
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
Red blood cell level
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
Hematocrit level
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
Serum iron level
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
Soluble transferrin receptor level
Time Frame
Week 0 (baseline) and Week 12
Title
Hepcidin-25 level
Time Frame
Week 0 (baseline) and Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hiroshima University
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan

12. IPD Sharing Statement

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Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

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