Effects of Iron on Exercise Capacity During Hypoxia

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265108
• Other study ID #: OHSRC-986
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2010
• Last updated: July 27, 2015
• Start date: November 2010
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Department of Physiology, Anatomy & Genetics, University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 8-h exposure to alveolar hypoxia.	No
Secondary	Maximal exercise capacity, assessed by peak power output.		After 8-h exposure to alveolar hypoxia.	No
Secondary	Pulmonary artery systolic pressure.		After 8-h exposure to alveolar hypoxia.	No
Secondary	Blood levels of oxygen-regulated proteins.		After 8-h exposure to alveolar hypoxia	No