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Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380548
First Posted: June 27, 2011
Last Update Posted: March 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SBI ALApromo Co., Ltd., Japan
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
  Purpose
This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.

Condition Intervention
Iron Deficiency Anemia 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia

Resource links provided by NLM:


Further study details as provided by Fumiko Higashikawa, Hiroshima University:

Primary Outcome Measures:
  • Hemoglobin level [ Time Frame: Every 4 weeks (Overall 20 weeks) ]

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

Estimated Enrollment: 135
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380548


Locations
Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
SBI ALApromo Co., Ltd., Japan
  More Information

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01380548     History of Changes
Other Study ID Numbers: eki-396
First Submitted: June 21, 2011
First Posted: June 27, 2011
Last Update Posted: March 28, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Aminolevulinic Acid
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents