Mountain SicknessCMSNCT01182792
Chronic Mountain Sickness, Systemic Vascular Function
A study testing Vitamin C and E in people with Mountain Sickness and Chronic, run by University of Lausanne Hospitals at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mountain Sickness, Chronic
- What is being tested?
- Vitamin C and E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2008to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with Chronic Mountain Sickness and their offspring
Who cannot join
- Smoking
- Lung disease
- Arterial Hypertension
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Bolivia1 site
Istituto Boliviano de Biologia de Altura, Universitad S. Andres
La Paz
Switzerland1 site
University Hospital Lausanne, Botnar Center for Extreme Medicine
Lausanne, Canton of Vaud, 1011
About this study
Official title: Chronic Hypoxemia and Systemic Vascular Function
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.
Preliminary data suggest that offspring of CMS patients may display pulmonary and systemic vascular dysfunction. Antioxidant administration is know to improve vascular function. We will test the acute effect of Vitamin C in this setting.
Finally, since there is considerable inter-individual variability of pulmonary artery pressure among CMS patients and the presence of a patent foramen ovale (PFO)is increased in clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the prevalence of PFO in healthy high altitude dwellers and in CMS patients and its effects on pulmonary artery pressure at rest and during mild exercise.
- Conditions
- Mountain Sickness, Chronic
- Being tested
- Vitamin C and E, Placebo
- Keywords
- Endothelial Function, Chronic Hypoxia, Oxidative Stress
- Medical subject headings
- Altitude Sickness, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C and EDietary supplement
1 month, 1g Vitamin C and 400 IE Vitamin E or Acute, 1g Vitamin C (in the offspring)
PlaceboDietary supplement
1 month Placebo
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant | Experimental | Not described Receives: Dietary Supplement: Vitamin C and E |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mountain SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Boliviano de Biologia de Altura, Universitad Major de S. Andres, La Paz, Bolivia
- Responsible party
- Principal investigator, Urs Scherrer, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182792
- Sponsor's protocol ID
- CMS
- Acronym
- CMS
- Status last verified
- Jun 2020
- First submitted
- 16 Aug 2010
- Last updated
- 16 Jun 2020
- Results posted
- No
Publications
Bailey DM, Culcasi M, Filipponi T, Brugniaux JV, Stacey BS, Marley CJ, Soria R, Rimoldi SF, Cerny D, Rexhaj E, Pratali L, Salmon CS, Jauregui CM, Villena M, Villafuerte F, Rockenbauer A, Pietri S, Scherrer U, Sartori C. EPR spectroscopic evidence of iron-catalysed free radical formation in chronic mountain sickness: Dietary causes and vascular consequences. Free Radic Biol Med. 2022 May 1;184:99-113. doi: 10.1016/j.freeradbiomed.2022.03.028. Epub 2022 Apr 6.
PubMed 35398201Rexhaj E, Rimoldi SF, Pratali L, Brenner R, Andries D, Soria R, Salinas C, Villena M, Romero C, Allemann Y, Lovis A, Heinzer R, Sartori C, Scherrer U. Sleep-Disordered Breathing and Vascular Function in Patients With Chronic Mountain Sickness and Healthy High-Altitude Dwellers. Chest. 2016 Apr;149(4):991-8. doi: 10.1378/chest.15-1450. Epub 2016 Jan 12.
PubMed 26540612Brenner R, Pratali L, Rimoldi SF, Murillo Jauregui CX, Soria R, Rexhaj E, Salinas Salmon C, Villena M, Romero C, Sartori C, Allemann Y, Scherrer U. Exaggerated pulmonary hypertension and right ventricular dysfunction in high-altitude dwellers with patent foramen ovale. Chest. 2015 Apr;147(4):1072-1079. doi: 10.1378/chest.14-1353.
PubMed 25375664Pratali L, Allemann Y, Rimoldi SF, Faita F, Hutter D, Rexhaj E, Brenner R, Bailey DM, Sartori C, Salmon CS, Villena M, Scherrer U, Picano E, Sicari R. RV contractility and exercise-induced pulmonary hypertension in chronic mountain sickness: a stress echocardiographic and tissue Doppler imaging study. JACC Cardiovasc Imaging. 2013 Dec;6(12):1287-97. doi: 10.1016/j.jcmg.2013.08.007. Epub 2013 Oct 23.
PubMed 24269266Bailey DM, Rimoldi SF, Rexhaj E, Pratali L, Salinas Salmon C, Villena M, McEneny J, Young IS, Nicod P, Allemann Y, Scherrer U, Sartori C. Oxidative-nitrosative stress and systemic vascular function in highlanders with and without exaggerated hypoxemia. Chest. 2013 Feb 1;143(2):444-451. doi: 10.1378/chest.12-0728.
PubMed 22922469Pratali L, Rimoldi SF, Rexhaj E, Hutter D, Faita F, Salmon CS, Villena M, Sicari R, Picano E, Allemann Y, Scherrer U, Sartori C. Exercise induces rapid interstitial lung water accumulation in patients with chronic mountain sickness. Chest. 2012 Apr;141(4):953-958. doi: 10.1378/chest.11-0084. Epub 2011 Sep 1.
PubMed 21885723Rimoldi SF, Rexhaj E, Pratali L, Bailey DM, Hutter D, Faita F, Salinas Salmon C, Villena M, Nicod P, Allemann Y, Scherrer U, Sartori C. Systemic vascular dysfunction in patients with chronic mountain sickness. Chest. 2012 Jan;141(1):139-146. doi: 10.1378/chest.11-0342. Epub 2011 Jun 23.
PubMed 21700688
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Hypoxemia and Systemic Vascular Function
- ClinicalTrials.gov ID
- NCT01182792
- Acronym / sponsor ID
- CMS / CMS
- Conditions
- Mountain Sickness, Chronic
- Keywords
- Endothelial Function, Chronic Hypoxia, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Instituto Boliviano de Biologia de Altura, Universitad Major de S. Andres, La Paz, Bolivia
- Study start
- Oct 2008
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Preliminary data suggest that offspring of CMS patients may display pulmonary and systemic vascular dysfunction. Antioxidant administration is know to improve vascular function. We will test the acute effect of Vitamin C in this setting.
Finally, since there is considerable inter-individual variability of pulmonary artery pressure among CMS patients and the presence of a patent foramen ovale (PFO)is increased in clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the prevalence of PFO in healthy high altitude dwellers and in CMS patients and its effects on pulmonary artery pressure at rest and during mild exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant | Experimental | Dietary Supplement: Vitamin C and E |
| Control | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Chronic Mountain Sickness and their offspring
Key exclusion criteria (3 listed)
- Smoking
- Lung disease
- Arterial Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C and E1 month, 1g Vitamin C and 400 IE Vitamin E or Acute, 1g Vitamin C (in the offspring) | Dietary supplement | Antioxidant |
| Placebo1 month Placebo | Dietary supplement | Control |
Primary outcome
Endothelial Function
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 35398201Bailey DM, Culcasi M, Filipponi T, Brugniaux JV, Stacey BS, Marley CJ, Soria R, Rimoldi SF, Cerny D, Rexhaj E, Pratali L, Salmon CS, Jauregui CM, Villena M, Villafuerte F, Rockenbauer A, Pietri S, Scherrer U, Sartori C. EPR spectroscopic evidence of iron-catalysed free radical formation in chronic mountain sickness: Dietary causes and vascular consequences. Free Radic Biol Med. 2022 May 1;184:99-113. doi: 10.1016/j.freeradbiomed.2022.03.028. Epub 2022 Apr 6.
- Derived from this study: PubMed 26540612Rexhaj E, Rimoldi SF, Pratali L, Brenner R, Andries D, Soria R, Salinas C, Villena M, Romero C, Allemann Y, Lovis A, Heinzer R, Sartori C, Scherrer U. Sleep-Disordered Breathing and Vascular Function in Patients With Chronic Mountain Sickness and Healthy High-Altitude Dwellers. Chest. 2016 Apr;149(4):991-8. doi: 10.1378/chest.15-1450. Epub 2016 Jan 12.
- Derived from this study: PubMed 25375664Brenner R, Pratali L, Rimoldi SF, Murillo Jauregui CX, Soria R, Rexhaj E, Salinas Salmon C, Villena M, Romero C, Sartori C, Allemann Y, Scherrer U. Exaggerated pulmonary hypertension and right ventricular dysfunction in high-altitude dwellers with patent foramen ovale. Chest. 2015 Apr;147(4):1072-1079. doi: 10.1378/chest.14-1353.
- Derived from this study: PubMed 24269266Pratali L, Allemann Y, Rimoldi SF, Faita F, Hutter D, Rexhaj E, Brenner R, Bailey DM, Sartori C, Salmon CS, Villena M, Scherrer U, Picano E, Sicari R. RV contractility and exercise-induced pulmonary hypertension in chronic mountain sickness: a stress echocardiographic and tissue Doppler imaging study. JACC Cardiovasc Imaging. 2013 Dec;6(12):1287-97. doi: 10.1016/j.jcmg.2013.08.007. Epub 2013 Oct 23.
- Derived from this study: PubMed 22922469Bailey DM, Rimoldi SF, Rexhaj E, Pratali L, Salinas Salmon C, Villena M, McEneny J, Young IS, Nicod P, Allemann Y, Scherrer U, Sartori C. Oxidative-nitrosative stress and systemic vascular function in highlanders with and without exaggerated hypoxemia. Chest. 2013 Feb 1;143(2):444-451. doi: 10.1378/chest.12-0728.
- Derived from this study: PubMed 21885723Pratali L, Rimoldi SF, Rexhaj E, Hutter D, Faita F, Salmon CS, Villena M, Sicari R, Picano E, Allemann Y, Scherrer U, Sartori C. Exercise induces rapid interstitial lung water accumulation in patients with chronic mountain sickness. Chest. 2012 Apr;141(4):953-958. doi: 10.1378/chest.11-0084. Epub 2011 Sep 1.
- Derived from this study: PubMed 21700688Rimoldi SF, Rexhaj E, Pratali L, Bailey DM, Hutter D, Faita F, Salinas Salmon C, Villena M, Nicod P, Allemann Y, Scherrer U, Sartori C. Systemic vascular dysfunction in patients with chronic mountain sickness. Chest. 2012 Jan;141(1):139-146. doi: 10.1378/chest.11-0342. Epub 2011 Jun 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C and E in people with Mountain Sickness and Chronic, run by University of Lausanne Hospitals at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bolivia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01182792, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.