Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01380548

Enrollment

135

Registered

2011-06-27

Start date

2011-06-30

Completion date

2012-12-31

Last updated

2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Placebo; once/day; for 12 weeks

DIETARY_SUPPLEMENTIron alone

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

DIETARY_SUPPLEMENTLow-dose 5-aminolevulinic acid with iron

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

DIETARY_SUPPLEMENTMedium-dose 5-aminolevulinic acid with iron

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

DIETARY_SUPPLEMENTHigh-dose 5-aminolevulinic acid with iron

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 49 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hemoglobin level	Every 4 weeks (Overall 20 weeks)

Secondary

Measure	Time frame
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)
Serum ferritin level	Every 4 weeks (Overall 20 weeks)
Hematocrit level	Every 4 weeks (Overall 20 weeks)
Serum iron level	Every 4 weeks (Overall 20 weeks)
Soluble transferrin receptor level	Week 0 (baseline) and Week 12
Hepcidin-25 level	Week 0 (baseline) and Week 12
Red blood cell level	Every 4 weeks (Overall 20 weeks)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026