NCT01380548已完成不适用
A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
This study is designed to evaluate efficacy and dose-dependency of 5-aminolevulinic acid in subjects with iron deficiency anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women with hemoglobin ≥ 9.0 g/dl and ≤ 12.0 g/dl
- •Willing not to donate blood during the study
- •Informed consent signed
排除标准
- •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
研究组 & 干预措施
Low-dose 5-aminolevulinic acid
Experimental
干预措施: Low-dose 5-aminolevulinic acid with iron (Dietary Supplement)
Medium-dose 5-aminolevulinic acid
Experimental
干预措施: Medium-dose 5-aminolevulinic acid with iron (Dietary Supplement)
High-dose 5-aminolevulinic acid
Experimental
干预措施: High-dose 5-aminolevulinic acid with iron (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
Iron alone
Placebo Comparator
干预措施: Iron alone (Dietary Supplement)
结局指标
主要结局
Hemoglobin level
时间窗: Every 4 weeks (Overall 20 weeks)
次要结局
- 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))
研究者
Fumiko Higashikawa
Associate Professor
Hiroshima University
研究点 (1)
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