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OpenTrials
Completed

NCT Number: NCT01265108

Effects of Iron on Exercise Capacity During Hypoxia

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Physiology, Anatomy & Genetics, University of Oxford

Oxford, OX1 3PT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron Sucrose.

Drug

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 names: Iron sucrose = Venofer

normal saline

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 22, 2010
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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