Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

March 26, 2013 updated by: Fumiko Higashikawa, Hiroshima University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 734-8551
        • Hiroshima University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
Placebo; once/day; for 12 weeks
PLACEBO_COMPARATOR: Iron alone
Dietary supplement: Iron alone
Iron (3 mg); once/day; for 12 weeks
EXPERIMENTAL: Low-dose 5-aminolevulinic acid
Dietary supplement: Low-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks
EXPERIMENTAL: Medium-dose 5-aminolevulinic acid
Dietary supplement: Medium-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks
EXPERIMENTAL: High-dose 5-aminolevulinic acid
Dietary supplement: High-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum ferritin level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)
Transferrin level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)
MCV level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)
TIBC level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)
Reticulocyte level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)
Red blood cell level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)
Hematocrit level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)
Serum iron level
Time Frame: Every 4 weeks (Overall 20 weeks)
Every 4 weeks (Overall 20 weeks)
Soluble transferrin receptor level
Time Frame: Week 0 (baseline) and Week 12
Week 0 (baseline) and Week 12
Hepcidin-25 level
Time Frame: Week 0 (baseline) and Week 12
Week 0 (baseline) and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hiroshima University

Collaborators

SBI ALApromo Co., Ltd., Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eki-396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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