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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014