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Status unknownNCT01182792CMSUpdated Jun 16, 2020

Chronic Mountain Sickness, Systemic Vascular Function

An interventional study of Vitamin C and E and Placebo in Mountain Sickness and Chronic, sponsored by University of Lausanne Hospitals. Status unknown at 2 sites in 2 countries. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
10 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Mountain Sickness
  • Chronic

Keywords

  • Endothelial Function
  • Chronic Hypoxia
  • Oxidative Stress
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In context

Altitude Sickness

216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.

This study's planned enrollment of 50 is above the median of 34 across 178 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 120 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with Chronic Mountain Sickness and their offspring

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Lung disease
  • Arterial Hypertension
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Antioxidant

    Dietary Supplement: Vitamin C and E

  • Placebo comparator
    Control

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementVitamin C and E

    Drug page: Ascorbic Acid

    1 month, 1g Vitamin C and 400 IE Vitamin E or Acute, 1g Vitamin C (in the offspring)

  • Dietary supplementPlacebo

    1 month Placebo

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What researchers measure

Primary outcomes

  1. Endothelial Function

    Time frame: 1 month

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Study locations

2 sites
  • Istituto Boliviano de Biologia de Altura, Universitad S. Andres
    La Paz, Bolivia
  • University Hospital Lausanne, Botnar Center for Extreme Medicine
    Lausanne, Vaud 1011, Switzerland
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References and documents

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 35398201 ↗
  • Rexhaj 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 26540612 ↗
  • Brenner 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 25375664 ↗
  • Pratali 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 24269266 ↗
  • Bailey 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 22922469 ↗
  • Pratali 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 21885723 ↗
  • Rimoldi 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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2008, a primary completion of Jun 2021 and a completion of Dec 2021. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2010
First posted
Aug 17, 2010
Start
Oct 2008
Primary completionEst.
Jun 2021
CompletionEst.
Dec 2021
Last update
Jun 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01182792
Collaborators
Instituto Boliviano de Biologia de Altura, Universitad Major de S. Andres, La Paz, Bolivia
Responsible party
Urs Scherrer (Prof, University of Lausanne Hospitals) — Principal investigator
First posted
Aug 17, 2010
Start date
Oct 2008
Primary completion
Jun 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jun 16, 2020
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ascorbic Acid

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