Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

This study has been completed.
Sponsor:
Collaborator:
SBI ALApromo Co., Ltd., Japan
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
ClinicalTrials.gov Identifier:
NCT01380548
First received: June 21, 2011
Last updated: March 26, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Hiroshima University:

Primary Outcome Measures:
  • Hemoglobin level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum ferritin level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Transferrin level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • MCV level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • TIBC level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Reticulocyte level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Red blood cell level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Hematocrit level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Serum iron level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Soluble transferrin receptor level [ Time Frame: Week 0 (baseline) and Week 12 ] [ Designated as safety issue: No ]
  • Hepcidin-25 level [ Time Frame: Week 0 (baseline) and Week 12 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 49 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380548

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

No publications provided

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01380548     History of Changes
Other Study ID Numbers: eki-396
Study First Received: June 21, 2011
Last Updated: March 26, 2013
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 23, 2014