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Effects of Iron on Exercise Capacity During Hypoxia

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ClinicalTrials.gov Identifier: NCT01265108
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
During alveolar hypoxia, for example at high altitude or in patients with respiratory disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might limit exercise performance. Intravenous iron supplementation has recently been shown to reverse pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary hypertension in volunteers exposed to hypoxia at sea level. The investigators hypothesized that intravenous iron supplementation would enhance exercise capacity during alveolar hypoxia.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Iron sucrose. Drug: Normal saline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.
Study Start Date : November 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : April 2015

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intravenous iron sucrose
Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline.
Drug: Iron sucrose.
Volunteers will receive an intravenous infusion of 200 mg iron sucrose, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas.
Other Name: Iron sucrose = Venofer
Placebo Comparator: Intravenous normal saline
Infusion of 100 ml normal (0.9%) saline.
Drug: Normal saline
Volunteers will receive an intravenous infusion of 100 ml normal saline, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas.



Primary Outcome Measures :
  1. Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption. [ Time Frame: After 8-h exposure to alveolar hypoxia. ]
    Volunteers will receive either intravenous iron or saline placebo, before exposure to 8 hours of alveolar hypoxia. They will then undergo an exercise test while breathing an hypoxic gas mixture. The primary outcome measure will be exercise capacity as determined by maximal oxygen consumption during this test. Volunteers will receive both interventions, via a crossover design. Due to uncertainty about the duration of action of iron at a cellular level, all volunteers will receive saline infusion on the first study day, and iron sucrose infusion on a second study day, at least one week later.


Secondary Outcome Measures :
  1. Maximal exercise capacity, assessed by peak power output. [ Time Frame: After 8-h exposure to alveolar hypoxia. ]
  2. Pulmonary artery systolic pressure. [ Time Frame: After 8-h exposure to alveolar hypoxia. ]
  3. Blood levels of oxygen-regulated proteins. [ Time Frame: After 8-h exposure to alveolar hypoxia ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 60 years
  • Sea level natives with no recent exposure to high altitude
  • Baseline iron indices within the normal range
  • Detectable tricuspid regurgitation on echocardiography

Exclusion Criteria:

  • Significant cardiorespiratory disease
  • Known susceptibility to high altitude-related illness
  • Taking medications or iron supplementation
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265108


Locations
United Kingdom
Department of Physiology, Anatomy & Genetics, University of Oxford
Oxford, United Kingdom, OX1 3PT
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Nick P Talbot, DPhil MRCP University of Oxford

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01265108     History of Changes
Other Study ID Numbers: OHSRC-986
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Iron
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics