Effects of 5-Aminolevulinic Acid on Iron Deficiency Anemia

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Iron alone; Dietary Supplement: Low-dose 5-aminolevulinic acid with iron; Dietary Supplement: Medium-dose 5-aminolevulinic acid with iron; Dietary Supplement: High-dose 5-aminolevulinic acid with iron

• Registration Number: NCT01380548
• Lead Sponsor: Hiroshima University

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 available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	Every 4 weeks (Overall 20 weeks)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima, Japan