Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia | NCT01380548

Studies
Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

NCT01380548

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Mar 28, 2013Estimated

Enrollment

135Estimated

Phase

Not Applicable

Conditions

Iron Deficiency Anemia

Interventions

Placebo
Iron alone
Low-dose 5-aminolevulinic acid with iron
Medium-dose 5-aminolevulinic acid with iron
High-dose 5-aminolevulinic acid with iron

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Jun 22, 2011

First Posted Date

Jun 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2013

Last Update Posted Date

Mar 28, 2013Estimated

Name	Class
SBI ALApromo Co., Ltd., Japan	UNKNOWN

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Dietary Supplement: Placebo
Iron alone	Placebo Comparator	Dietary Supplement: Iron alone
Low-dose 5-aminolevulinic acid	Experimental	Dietary Supplement: Low-dose 5-aminolevulinic acid with iron
Medium-dose 5-aminolevulinic acid	Experimental	Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron
High-dose 5-aminolevulinic acid	Experimental	Dietary Supplement: High-dose 5-aminolevulinic acid with iron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Placebo; once/day; for 12 weeks	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin level		Every 4 weeks (Overall 20 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Serum ferritin level		Every 4 weeks (Overall 20 weeks)
Transferrin level		Every 4 weeks (Overall 20 weeks)
MCV level

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima		734-8551	Japan

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007501	Iron
D000622	Aminolevulinic Acid

Ancestor Terms

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements

Browse Leaves

Not provided

Browse Branches

Not provided