Effects of Iron on Exercise Capacity During Hypoxia

NCT ID: NCT01265108

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Intravenous iron sucrose

Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline.

Group Type: EXPERIMENTAL

Iron sucrose.

Intervention Type: 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.

Intravenous normal saline

Infusion of 100 ml normal (0.9%) saline.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Iron sucrose = Venofer

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick P Talbot, DPhil MRCP

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Department of Physiology, Anatomy & Genetics, University of Oxford

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

OHSRC-986

Identifier Type: -

Identifier Source: org_study_id