Trial | NCT01380548  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    iron aminolevulinic acid ...

  • Study Participants

    135
This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.
Study Started
Jun 30
2011
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
Mar 28
2013
Estimate

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

Placebo Placebo Comparator

Iron alone Placebo Comparator

Low-dose 5-aminolevulinic acid Experimental

Medium-dose 5-aminolevulinic acid Experimental

High-dose 5-aminolevulinic acid Experimental

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
No Results Posted