NCT01380548

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

June 21, 2011

Last Update Submit

March 26, 2013

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin level

    Every 4 weeks (Overall 20 weeks)

Secondary Outcomes (10)

  • Serum ferritin level

    Every 4 weeks (Overall 20 weeks)

  • Transferrin level

    Every 4 weeks (Overall 20 weeks)

  • MCV level

    Every 4 weeks (Overall 20 weeks)

  • TIBC level

    Every 4 weeks (Overall 20 weeks)

  • Reticulocyte level

    Every 4 weeks (Overall 20 weeks)

  • +5 more secondary outcomes

Study Arms (5)

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

PlaceboDIETARY_SUPPLEMENT

Placebo; once/day; for 12 weeks

Placebo
Iron aloneDIETARY_SUPPLEMENT

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

Iron alone
Low-dose 5-aminolevulinic acid with ironDIETARY_SUPPLEMENT

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

Low-dose 5-aminolevulinic acid
Medium-dose 5-aminolevulinic acid with ironDIETARY_SUPPLEMENT

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

Medium-dose 5-aminolevulinic acid
High-dose 5-aminolevulinic acid with ironDIETARY_SUPPLEMENT

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

High-dose 5-aminolevulinic acid

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women with hemoglobin ≥ 9.0 g/dl and ≤ 12.0 g/dl
  • Willing not to donate blood during the study
  • Informed consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, 734-8551, Japan

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

IronAminolevulinic Acid

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsLevulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 27, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 28, 2013

Record last verified: 2013-03

Locations

JP(1)