NCT01571687

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

March 28, 2012

Last Update Submit

April 3, 2012

Conditions

Oxidative StressCell-derived Microparticles

Keywords

expeditionhypoxiablood coagulation disorderscell-derived microparticlesoxidative stressN-Acetylcysteinvitamins

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in oxidative stress

    during expedition, up to 22 days

Secondary Outcomes (3)

  • Change from baseline in coagulation activation

    during expedition, up to 22 days

  • Change from baseline in acute mountain sickness score

    during expedition, up to 22 days

  • Change from baseline in oxygen saturation in blood

    during expedition, up to 22 days

Study Arms (2)

antioxidant supplements

ACTIVE COMPARATOR

800 I.E. Vitamin E, 1000mg Vitamin C, 200000 I.E. Vitamin A, 600mg Acetylcystein.

Dietary Supplement: antioxidant supplements

Placebo

PLACEBO COMPARATOR

identically appearing placebo

Dietary Supplement: Placebo

Interventions

antioxidant supplementsDIETARY_SUPPLEMENT

Intake of 6 tablets daily containing: 800 I.E. Vitamin E, 1000mg Vitamin C, 200000 I.E. Vitamin A, 600mg Acetylcystein.

antioxidant supplements
PlaceboDIETARY_SUPPLEMENT

Intake of 6 identically appearing tablets daily containing placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • good health status
  • age 18-65
  • mountaineering experience

You may not qualify if:

  • any metabolic disorders
  • regular drug intake
  • any disease of the lungs
  • any disease of the heart
  • any renal abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Laboratory Medicine Cantonal Hospital Aarau and University of Bern

Aarau, 5001, Switzerland

Location

Related Publications (5)

  • Basnyat B, Murdoch DR. High-altitude illness. Lancet. 2003 Jun 7;361(9373):1967-74. doi: 10.1016/S0140-6736(03)13591-X.

    PMID: 12801752BACKGROUND

  • Hackett 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.

    PMID: 62991BACKGROUND

  • Taniyama 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.

    PMID: 14581295BACKGROUND

  • Huet 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.

    PMID: 21196278BACKGROUND

  • Pichler 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.

    PMID: 19950043RESULT

MeSH Terms

Conditions

HypoxiaBlood Coagulation Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Andreas R Huber, Prof. Dr. med.

    Center of Laboratory Medicine Cantonal Hospital Aarau and University of Bern

    STUDY CHAIR

  • Jacqueline Pichler Hefti, Dr. med.

    Division of Pneumology, Inselspital Bern, Universityhospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

April 5, 2012

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

CH(1)