Back to resultsEffects of Iron on Exercise Capacity During Hypoxia
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Iron sucrose.
Normal saline
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers
Eligibility 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
Sites / Locations
- Department of Physiology, Anatomy & Genetics, University of Oxford
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intravenous iron sucrose
Intravenous normal saline
Arm Description
Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline.
Infusion of 100 ml normal (0.9%) saline.
Outcomes
Primary Outcome Measures
Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption.
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
Maximal exercise capacity, assessed by peak power output.
Pulmonary artery systolic pressure.
Blood levels of oxygen-regulated proteins.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01265108
Brief Title
Effects of Iron on Exercise Capacity During Hypoxia
Official Title
Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous iron sucrose
Arm Type
Experimental
Arm Description
Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline.
Arm Title
Intravenous normal saline
Arm Type
Placebo Comparator
Arm Description
Infusion of 100 ml normal (0.9%) saline.
Intervention Type
Drug
Intervention Name(s)
Iron sucrose.
Other Intervention Name(s)
Iron sucrose = Venofer
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
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 Measure Information:
Title
Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption.
Description
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.
Time Frame
After 8-h exposure to alveolar hypoxia.
Secondary Outcome Measure Information:
Title
Maximal exercise capacity, assessed by peak power output.
Time Frame
After 8-h exposure to alveolar hypoxia.
Title
Pulmonary artery systolic pressure.
Time Frame
After 8-h exposure to alveolar hypoxia.
Title
Blood levels of oxygen-regulated proteins.
Time Frame
After 8-h exposure to alveolar hypoxia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick P Talbot, DPhil MRCP
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physiology, Anatomy & Genetics, University of Oxford
City
Oxford
ZIP/Postal Code
OX1 3PT
Country
United Kingdom
12. IPD Sharing Statement
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Effects of Iron on Exercise Capacity During Hypoxia
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