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临床试验/NCT01926132
NCT01926132Unknown4 期

High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study

Yonsei University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
fatigue scale

研究概览

简要总结

Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids, proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA. Ascorbic acid was known to protect mitochondrial injury against oxidative stress by depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function. There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The investigators will compare the mtDNA copy number and fatigue scale between moderate-severe fatigue patients and control group that had not malignant and chronic illness by a randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with above 18 years old and 6 month fatigue duration
  • Moderate to severe fatigue scale (Brief fatigue inventory-Korean version scale ≥ 4)
  • Normal limit values in the screening test (White blood cell count, Hemoglobin, Creatinine, SGOT/SGPT, Thyroid stimulating hormone, Urinalysis)
  • Normal limit values in glucose 6 phosphate dehydrogenase level
  • Agree the subjects explanation

排除标准

  • pregnancy and lactation
  • acute common cold, acute gastroenteritis, uncontrolled diabetes, uncontrolled hypertension, liver disease or renal disease
  • previous medical history, affectable by high-dose ascorbic acid (gout, renal calculi and glucose 6 phosphate dehydrogenase deficiency)
  • hypersensitivity from ascorbic acid
  • vitamin supplement intake until 2 days ago
  • drug interactions with ascorbic acid ( aspirin, Fe, phenytoin, estrogen, tetracycline, coumarin, corticosteroid)
  • Do not read a consent fom

研究组 & 干预措施

ascorbic acid 10g/20ml

Experimental

Normal Saline 130ml+ ascorbic acid 10g/20ml , covered bottle for the blind allocation

干预措施: ascorbic acid 10g/20ml (Drug)

Normal Saline 150ml

Active Comparator

Normal Saline 150ml, covered bottle

干预措施: Normal Saline 150ml (Drug)

结局指标

主要结局

fatigue scale

时间窗: 2 weeks after 10g ascorbic aicd intravenous injection

次要结局

  • mitochondrial DNA copy number on blood and salivary samples(2 weeks after 10g ascorbic aicd intravenous injection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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