Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380548
• Other study ID #: eki-396
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: March 26, 2013
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Dietary Supplement:
• Placebo
Placebo; once/day; for 12 weeks
• Iron alone
Iron (3 mg); once/day; for 12 weeks
• Low-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks
• Medium-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks
• High-dose 5-aminolevulinic acid with iron
5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	SBI ALApromo Co., Ltd., Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Serum ferritin level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Transferrin level		Every 4 weeks (Overall 20 weeks)	No
Secondary	MCV level		Every 4 weeks (Overall 20 weeks)	No
Secondary	TIBC level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Reticulocyte level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Red blood cell level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Hematocrit level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Serum iron level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Soluble transferrin receptor level		Week 0 (baseline) and Week 12	No
Secondary	Hepcidin-25 level		Week 0 (baseline) and Week 12	No