Randomized Controlled Trial of N-acetylcysteine and Acetazolamide in Treatment of Chronic Mountain Sickness
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8
研究概览
简要总结
Chronic mountain sickness is characterized by excessive red blood cell production which causes sludging of the vascular system. This high viscosity blood causes heart failure, cognitive dysfunction, and strokes. The investigators hypothesize that cobalt which has been previously been shown to be an environmental pollutant worsens the overproduction of red blood cells. The investigators plan to conduct a 6 week trial in which acetazolamide (already shown to improve chronic mountain sickness) and N-acetylcysteine (a drug that removes cobalt from the blood) are evaluated in their potential to improve chronic mountain sickness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males over 17 years of age
- •Hematocrit > 70%
- •Chronic Mountain Sickness score (CMS) > 6
- •Able to give informed consent and follow instructions in written Spanish
排除标准
- •CMS > 15
- •Underlying lung disease, smoking, or oxygen therapy
- •Asthma (bronchospasm can be caused by N-acetylcysteine)
- •Phlebotomy in last 3 months
- •h/o adverse reaction to acetazolamide or N-acetylcysteine
研究组 & 干预措施
Placebo pills
干预措施: Placebo pills (Drug)
Acetazolamide alone
干预措施: Acetazolamide (Drug)
Acetazolamide alone
干预措施: Placebo pills (Drug)
N-acetylcysteine alone
干预措施: N-acetylcysteine (Drug)
N-acetylcysteine alone
干预措施: Placebo pills (Drug)
Combination of N-acetylcysteine and acetazolamide
干预措施: N-acetylcysteine (Drug)
Combination of N-acetylcysteine and acetazolamide
干预措施: Acetazolamide (Drug)
结局指标
主要结局
Change from baseline in Hematocrit, or fraction of plasma occupied by cellular elements at week 8
时间窗: Baseline and week 8
Spun hematocrit measured on portable machine
次要结局
- Change from baseline in arterial blood gas values at week 8(Baseline and week 8)
- Change in baseline urine protein at 8 weeks(Baseline and week 8)
- Change in baseline Chronic mountain sickness score at 8 weeks(Baseline and week 8)
- Change from baseline Erythropoietin at week 8(Baseline and week 8)
- Change from baseline in serum and urine Cobalt at day 3(Baseline and day 3)
- Changes in baseline Serum electrolytes at day 3, 14 and week 8(Baseline and Days 3, 14, and week 8)