Oxidative StressPLHARENCT01571687
Pik Lenin High Altitude Research Expedition 2009
A study testing antioxidant supplements in people with Oxidative Stress and Cell-derived Microparticles, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Exposure to hypobaric hypoxia demands maximum effort of the body and can lead to high altitude illnesses. Recently, there is rising interest on coagulation activation during trekking and mountaineering in higher regions and on development of oxidative stress due to hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Cell-derived Microparticles
- What is being tested?
- antioxidant supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2009to Aug 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good health status
- age 18-65
- mountaineering experience
Who cannot join
- any metabolic disorders
- regular drug intake
- any disease of the lungs
- any disease of the heart
- any renal abnormality
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center of Laboratory Medicine Cantonal Hospital Aarau and University of Bern
Aarau, 5001
About this study
Official title: Pik Lenin High Altitude Research Expedition 2009, a Follow-up Project of the Muztagh Ata High Altitude Research Expedition 2005
Exposure to hypobaric hypoxia demands maximum effort of the body and can lead to high altitude illnesses. Recently, there is rising interest on coagulation activation during trekking and mountaineering in higher regions and on development of oxidative stress due to hypoxia. 30 volunteers have been examined during an high altitude research expedition to the 7134m high mount Pik Lenin in Kyrgyzstan to investigate mechanisms of coagulation activation and effects of antioxidant supplements on oxidative stress.
Read the detailed description
Reactions to acute exposure to high altitude and the process of acclimatization has been of scientific interest since many years. High altitude illnesses are specified by three different entities: acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE). Prevalence of AMS is known to be between 10 to 20% for altitudes between 4000 and 5000m, increasing significantly in higher altitude. The prevalence depends on the ascent rate, individual susceptibility and physical exhaustion.
Although mechanisms leading to high altitude illnesses are not yet completely clear some progress has been made. It is well accepted that excessive pulmonary hypertension may lead to HAPE. Furthermore, there is rising evidence about endothelial dysfunction being involved in disease progression. Some cellular and molecular mechanisms of acute (hypobaric) hypoxia, possibly leading to endothelial dysfunction, have been studied in a few experimental and field settings. Paradoxical increase in systemic oxidative stress is seen under hypoxic conditions, such as high altitude stay. Reactive oxygen species (ROS) could be demonstrated in many endothelial disorders and capillary leakage syndromes such as septicaemia, myocardial infarct and stroke. Furthermore, coagulation activation might result from endothelial dysfunction but also amplify endothelial interruption. Still, most of our knowledge concerning effects of hypoxia in general but also concerning oxidative stress is from in vitro studies (e.g. cancer cells).
In the context of a high altitude expedition human subjects can safely be submitted to prolonged hypoxia to explore generation of ROS and extent of procoagulatory state.
Objective
The purpose of our study is to confirm excessive oxidative stress found in our previous study in 2005 and to investigate whether oxidative stress during high altitude exposure can be modified by dietary supplementations of specific antioxidants. Moreover, we like to study mechanisms of coagulation activation by assessing extent of thrombocytic and endothelial microparticles.
Methods
After approval of the study by the regional ethics committee, written informed consent has been obtained from 30 healthy volunteers (low land residents with mountaineering experience, age 18-65 years). After baseline testing, double-blind randomization into 2 groups of 15 persons took place. One group received oral medication with vitamin E, vitamin C, vitamin A and acetylcystein daily, while the other group was provided with an identical appearing placebo preparation. Substitution started 2 month before the expedition. After examination at "ground 0" in Zurich (409m) all members underwent testing in Base Camp (3550m), twice in advanced Base Camp (4550m), in Camp 1 (5430m), and in Camp 2 (6265m). Beside blood sampling, clinical examinations were performed. Metabolomics, a mass-spectrometry based analysis, for measurement of oxidative stress, will be performed. In a subgroup microparticles will be detected by annexin V based ELISA and by flow cytometry using specific antibodies.
- Conditions
- Oxidative Stress, Cell-derived Microparticles
- Being tested
- antioxidant supplements, Placebo
- Keywords
- expedition, hypoxia, blood coagulation disorders, cell-derived microparticles, oxidative stress, N-Acetylcystein, vitamins
- Medical subject headings
- Hypoxia, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antioxidant supplementsDietary supplement
Intake of 6 tablets daily containing: 800 I.E. Vitamin E, 1000mg Vitamin C, 200000 I.E. Vitamin A, 600mg Acetylcystein.
PlaceboDietary supplement
Intake of 6 identically appearing tablets daily containing placebo
| Study group | Role | What they receive |
|---|---|---|
| antioxidant supplements | Active comparator | 800 I.E. Vitamin E, 1000mg Vitamin C, 200000 I.E. Vitamin A, 600mg Acetylcystein. Receives: Dietary Supplement: antioxidant supplements |
| Placebo | Placebo comparator | identically appearing placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in oxidative stress
Measured: during expedition, up to 22 days
Secondary outcomes (3)
Change from baseline in coagulation activation
Measured: during expedition, up to 22 days
Change from baseline in acute mountain sickness score
Measured: during expedition, up to 22 days
Change from baseline in oxygen saturation in blood
Measured: during expedition, up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Aarau, Lotteriefonds des Kantons Aarau, Schweizer Gesellschaft für Gebirgsmedizin, University of Bern
- Responsible party
- Sponsor
- Investigators
- Andreas R Huber, Prof. Dr. med., Study chair, Center of Laboratory Medicine Cantonal Hospital Aarau and University of BernJacqueline Pichler Hefti, Dr. med., Principal investigator, Division of Pneumology, Inselspital Bern, Universityhospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571687
- Sponsor's protocol ID
- 2008/071
- Other IDs
- 07.09.34
- Acronym
- PLHARE
- Status last verified
- Apr 2012
- First submitted
- 28 Mar 2012
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Basnyat B, Murdoch DR. High-altitude illness. Lancet. 2003 Jun 7;361(9373):1967-74. doi: 10.1016/S0140-6736(03)13591-X.
PubMed 12801752Hackett PH, Rennie D, Levine HD. The incidence, importance, and prophylaxis of acute mountain sickness. Lancet. 1976 Nov 27;2(7996):1149-55. doi: 10.1016/s0140-6736(76)91677-9.
PubMed 62991Taniyama Y, Griendling KK. Reactive oxygen species in the vasculature: molecular and cellular mechanisms. Hypertension. 2003 Dec;42(6):1075-81. doi: 10.1161/01.HYP.0000100443.09293.4F. Epub 2003 Oct 27.
PubMed 14581295Huet O, Dupic L, Harrois A, Duranteau J. Oxidative stress and endothelial dysfunction during sepsis. Front Biosci (Landmark Ed). 2011 Jan 1;16(5):1986-95. doi: 10.2741/3835.
PubMed 21196278Pichler Hefti J, Risch L, Hefti U, Scharrer I, Risch G, Merz TM, Turk A, Bosch MM, Barthelmess D, Schoch O, Maggiorini M, Huber AR. Changes of coagulation parameters during high altitude expedition. Swiss Med Wkly. 2010 Feb 20;140(7-8):111-7. doi: 10.4414/smw.2010.12910.
PubMed 19950043
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pik Lenin High Altitude Research Expedition 2009, a Follow-up Project of the Muztagh Ata High Altitude Research Expedition 2005
- ClinicalTrials.gov ID
- NCT01571687
- Acronym / sponsor ID
- PLHARE / 2008/071
- Conditions
- Oxidative Stress, Cell-derived Microparticles
- Keywords
- expedition, hypoxia, blood coagulation disorders, cell-derived microparticles, oxidative stress, N-Acetylcystein, vitamins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Kantonsspital Aarau, Lotteriefonds des Kantons Aarau, Schweizer Gesellschaft für Gebirgsmedizin, University of Bern
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 5 Apr 2012 (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.
Exposure to hypobaric hypoxia demands maximum effort of the body and can lead to high altitude illnesses. Recently, there is rising interest on coagulation activation during trekking and mountaineering in higher regions and on development of oxidative stress due to hypoxia. 30 volunteers have been examined during an high altitude research expedition to the 7134m high mount Pik Lenin in Kyrgyzstan to investigate mechanisms of coagulation activation and effects of antioxidant supplements on oxidative stress.
Detailed description
Reactions to acute exposure to high altitude and the process of acclimatization has been of scientific interest since many years. High altitude illnesses are specified by three different entities: acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE). Prevalence of AMS is known to be between 10 to 20% for altitudes between 4000 and 5000m, increasing significantly in higher altitude. The prevalence depends on the ascent rate, individual susceptibility and physical exhaustion.
Although mechanisms leading to high altitude illnesses are not yet completely clear some progress has been made. It is well accepted that excessive pulmonary hypertension may lead to HAPE. Furthermore, there is rising evidence about endothelial dysfunction being involved in disease progression. Some cellular and molecular mechanisms of acute (hypobaric) hypoxia, possibly leading to endothelial dysfunction, have been studied in a few experimental and field settings. Paradoxical increase in systemic oxidative stress is seen under hypoxic conditions, such as high altitude stay. Reactive oxygen species (ROS) could be demonstrated in many endothelial disorders and capillary leakage syndromes such as septicaemia, myocardial infarct and stroke. Furthermore, coagulation activation might result from endothelial dysfunction but also amplify endothelial interruption. Still, most of our knowledge concerning effects of hypoxia in general but also concerning oxidative stress is from in vitro studies (e.g. cancer cells).
In the context of a high altitude expedition human subjects can safely be submitted to prolonged hypoxia to explore generation of ROS and extent of procoagulatory state.
Objective
The purpose of our study is to confirm excessive oxidative stress found in our previous study in 2005 and to investigate whether oxidative stress during high altitude exposure can be modified by dietary supplementations of specific antioxidants. Moreover, we like to study mechanisms of coagulation activation by assessing extent of thrombocytic and endothelial microparticles.
Methods
After approval of the study by the regional ethics committee, written informed consent has been obtained from 30 healthy volunteers (low land residents with mountaineering experience, age 18-65 years). After baseline testing, double-blind randomization into 2 groups of 15 persons took place. One group received oral medication with vitamin E, vitamin C, vitamin A and acetylcystein daily, while the other group was provided with an identical appearing placebo preparation. Substitution started 2 month before the expedition. After examination at "ground 0" in Zurich (409m) all members underwent testing in Base Camp (3550m), twice in advanced Base Camp (4550m), in Camp 1 (5430m), and in Camp 2 (6265m). Beside blood sampling, clinical examinations were performed. Metabolomics, a mass-spectrometry based analysis, for measurement of oxidative stress, will be performed. In a subgroup microparticles will be detected by annexin V based ELISA and by flow cytometry using specific antibodies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antioxidant supplements | Active comparator | Dietary Supplement: antioxidant supplements800 I.E. Vitamin E, 1000mg Vitamin C, 200000 I.E. Vitamin A, 600mg Acetylcystein. |
| Placebo | Placebo comparator | Dietary Supplement: Placeboidentically appearing placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- good health status
- age 18-65
- mountaineering experience
Key exclusion criteria (5 listed)
- any metabolic disorders
- regular drug intake
- any disease of the lungs
- any disease of the heart
- any renal abnormality
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 |
|---|---|---|
| antioxidant supplementsIntake of 6 tablets daily containing: 800 I.E. Vitamin E, 1000mg Vitamin C, 200000 I.E. Vitamin A, 600mg Acetylcystein. | Dietary supplement | antioxidant supplements |
| PlaceboIntake of 6 identically appearing tablets daily containing placebo | Dietary supplement | Placebo |
Primary outcome
Change from baseline in oxidative stress
Time frame: during expedition, up to 22 days
3 secondary outcomes
Change from baseline in coagulation activation
Time frame: during expedition, up to 22 days
Change from baseline in acute mountain sickness score
Time frame: during expedition, up to 22 days
Change from baseline in oxygen saturation in blood
Time frame: during expedition, up to 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
- Background: PubMed 12801752Basnyat B, Murdoch DR. High-altitude illness. Lancet. 2003 Jun 7;361(9373):1967-74. doi: 10.1016/S0140-6736(03)13591-X.
- Background: PubMed 62991Hackett PH, Rennie D, Levine HD. The incidence, importance, and prophylaxis of acute mountain sickness. Lancet. 1976 Nov 27;2(7996):1149-55. doi: 10.1016/s0140-6736(76)91677-9.
- Background: PubMed 14581295Taniyama Y, Griendling KK. Reactive oxygen species in the vasculature: molecular and cellular mechanisms. Hypertension. 2003 Dec;42(6):1075-81. doi: 10.1161/01.HYP.0000100443.09293.4F. Epub 2003 Oct 27.
- Background: PubMed 21196278Huet O, Dupic L, Harrois A, Duranteau J. Oxidative stress and endothelial dysfunction during sepsis. Front Biosci (Landmark Ed). 2011 Jan 1;16(5):1986-95. doi: 10.2741/3835.
- Results publication: PubMed 19950043Pichler Hefti J, Risch L, Hefti U, Scharrer I, Risch G, Merz TM, Turk A, Bosch MM, Barthelmess D, Schoch O, Maggiorini M, Huber AR. Changes of coagulation parameters during high altitude expedition. Swiss Med Wkly. 2010 Feb 20;140(7-8):111-7. doi: 10.4414/smw.2010.12910.
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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.
Andreas R Huber, Prof. Dr. med. study chair
Center of Laboratory Medicine Cantonal Hospital Aarau and University of Bern
Jacqueline Pichler Hefti, Dr. med. principal investigator
Division of Pneumology, Inselspital Bern, Universityhospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antioxidant supplements in people with Oxidative Stress and Cell-derived Microparticles, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in oxidative stress (time frame: during expedition, up to 22 days). 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 NCT01571687, which also lists 5 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 5 Apr 2012.