Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

Hiroshima University

Status: Completed

Conditions: Iron Deficiency Anemia

Treatments: Dietary Supplement: High-dose 5-aminolevulinic acid with iron; Dietary Supplement: Placebo; Dietary Supplement: Low-dose 5-aminolevulinic acid with iron; Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron; Dietary Supplement: Iron alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01380548

eki-396

Details and patient eligibility

About

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

Enrollment: 135 estimated patients

Sex: Female

Ages: 20 to 49 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Iron alone

Placebo Comparator group

Treatment:

Dietary Supplement: Iron alone

Low-dose 5-aminolevulinic acid

Experimental group

Treatment:

Dietary Supplement: Low-dose 5-aminolevulinic acid with iron

Medium-dose 5-aminolevulinic acid

Experimental group

Treatment:

Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron

High-dose 5-aminolevulinic acid

Experimental group

Treatment:

Dietary Supplement: High-dose 5-aminolevulinic acid with iron