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Completed

NCT Number: NCT01380548

Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

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

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Placebo; once/day; for 12 weeks

Iron alone

Dietary Supplement

Iron (3 mg); once/day; for 12 weeks

Low-dose 5-aminolevulinic acid with iron

Dietary Supplement

5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks

Medium-dose 5-aminolevulinic acid with iron

Dietary Supplement

5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks

High-dose 5-aminolevulinic acid with iron

Dietary Supplement

5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks

Primary outcomes

  1. Hemoglobin level

    Time frame: Every 4 weeks (Overall 20 weeks)

Secondary outcomes

  1. Serum ferritin level

    Time frame: Every 4 weeks (Overall 20 weeks)

  2. Transferrin level

    Time frame: Every 4 weeks (Overall 20 weeks)

  3. MCV level

    Time frame: Every 4 weeks (Overall 20 weeks)

  4. TIBC level

    Time frame: Every 4 weeks (Overall 20 weeks)

  5. Reticulocyte level

    Time frame: Every 4 weeks (Overall 20 weeks)

  6. Red blood cell level

    Time frame: Every 4 weeks (Overall 20 weeks)

  7. Hematocrit level

    Time frame: Every 4 weeks (Overall 20 weeks)

  8. Serum iron level

    Time frame: Every 4 weeks (Overall 20 weeks)

  9. Soluble transferrin receptor level

    Time frame: Week 0 (baseline) and Week 12

  10. Hepcidin-25 level

    Time frame: Week 0 (baseline) and Week 12

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • SBI ALApromo Co., Ltd., Japan

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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