Chronic Mountain Sickness, Systemic Vascular Function (CMS)
Recruitment status was Recruiting
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Purpose
Diseases associated with chronic hypoxemia like chronic obstructive pulmonary disease (COPD) or emphysema, represent major medical and socio-economical problems and one of the leading cause of morbidity and mortality in the western countries. Recently, is has been shown that cardiovascular (CV) diseases contribute highly to the morbidity and mortality of these patients. Furthermore, increasing evidence suggest that systemic vascular dysfunction play a central role in the mediation of the increased CV risk in patients with COPD. However the underlying mechanisms of vascular dysfunction in these patients are incompletely understood. Chronic mountain sickness (CMS) is characterized by chronic hypoxemia related at least in part to hypoventilation; it affects relatively young adults, and may therefore allow to study the effects of chronic hypoxemia. The investigators therefore will assess systemic vascular function and test the hypothesis that increased oxidative stress is responsible for this dysfunction. Since polyglobulia is a hallmark of chronic hypoxemia and has been suggested to affect vascular function, the investigators will test the effects of hemodilution on vascular function. Then, the investigators will test the effects of acute oxygen application and 1 month antioxidative dietary supplement on vascular function.
| Condition | Intervention |
|---|---|
|
Mountain Sickness Chronic |
Dietary Supplement: Vitamin C and E Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Chronic Hypoxemia and Systemic Vascular Function |
- Endothelial Function [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Antioxidant |
Dietary Supplement: Vitamin C and E
1 month, 1g Vitamin C and 400 IE Vitamin E
|
| Placebo Comparator: Control |
Dietary Supplement: Placebo
1 month Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients with Chronic Mountain Sickness
Exclusion Criteria:
- Smoking
- Lung disease
- Arterial Hypertension
Contacts and Locations| Contact: Urs Scherrer, Prof. M.D. | +41 21 314 09 30 | urs.scherrer@chuv.ch |
| Contact: Claudio Sartori, Prof. M.D. | +41 21 314 09 30 | claudio.sartori@chuv.ch |
| Bolivia | |
| Istituto Boliviano de Biologia de Altura, Universitad S. Andres | Recruiting |
| La Paz, Bolivia | |
| Contact: Mercedes Villena, M.D. +591 2 224 20 64 villenamercedes@hotmail.com | |
| Principal Investigator: Mercedes Villena, M.D. | |
| Switzerland | |
| University Hospital Lausanne, Botnar Center for Extreme Medicine | Recruiting |
| Lausanne, Vaud, Switzerland, 1011 | |
| Contact: Urs Scherrer, Prof. M. D. +41 21 314 09 30 urs.scherrer@chuv.ch | |
| Contact: Claudio Sartori, Prof. M.D. +41 21 314 09 30 claudio.sartori@chuv.ch | |
| Principal Investigator: Urs Scherrer, Prof. M.D. | |
| Sub-Investigator: Claudio Sartori, Prof. M.D. | |
More Information
No publications provided by University of Lausanne Hospitals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Urs Scherrer, Prof. M.D., University of Lausanne, Botnar Center for Extreme Medicine |
| ClinicalTrials.gov Identifier: | NCT01182792 History of Changes |
| Other Study ID Numbers: | CMS |
| Study First Received: | August 16, 2010 |
| Last Updated: | August 16, 2010 |
| Health Authority: | Switzerland: Federal Office of Public Health |
Keywords provided by University of Lausanne Hospitals:
|
Endothelial Function Chronic Hypoxia Oxidative Stress |
Additional relevant MeSH terms:
|
Altitude Sickness Respiration Disorders Respiratory Tract Diseases Ascorbic Acid Vitamins Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013