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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 21, 2011
Last Updated Date	March 26, 2013
Start Date ^ICMJE	June 2011
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 22, 2011)	Hemoglobin level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01380548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 7, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 22, 2011)	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 ] Hepsidin-25 level [ Time Frame: Week 0 (baseline) and Week 12 ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia
Official Title ^ICMJE	A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia
Brief Summary	This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Iron Deficiency Anemia
Intervention ^ICMJE	Dietary Supplement: Placebo Placebo; once/day; for 12 weeks Dietary Supplement: Iron alone Iron (3 mg); once/day; for 12 weeks Dietary Supplement: Low-dose 5-aminolevulinic acid with iron 5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron 5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks Dietary Supplement: High-dose 5-aminolevulinic acid with iron 5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks
Study Arm (s)	Placebo Comparator: Placebo Intervention: Dietary Supplement: Placebo Placebo Comparator: Iron alone Intervention: Dietary Supplement: Iron alone Experimental: Low-dose 5-aminolevulinic acid Intervention: Dietary Supplement: Low-dose 5-aminolevulinic acid with iron Experimental: Medium-dose 5-aminolevulinic acid Intervention: Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron Experimental: High-dose 5-aminolevulinic acid Intervention: Dietary Supplement: High-dose 5-aminolevulinic acid with iron
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	135
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	20 Years to 49 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01380548
Other Study ID Numbers ^ICMJE	eki-396
Has Data Monitoring Committee	Not Provided
Responsible Party	Fumiko Higashikawa, Hiroshima University
Study Sponsor ^ICMJE	Hiroshima University
Collaborators ^ICMJE	SBI ALApromo Co., Ltd., Japan
Investigators ^ICMJE	Not Provided
Information Provided By	Hiroshima University
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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