Effects of Iron on Exercise Capacity During Hypoxia

University of Oxford

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Normal saline; Drug: Iron sucrose.

Study type: Interventional

Funder types: Other

Identifiers

NCT01265108

OHSRC-986

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

12 participants in 2 patient groups, including a placebo group

Intravenous iron sucrose

Experimental group

Description:

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

Treatment:

Drug: Iron sucrose.

Intravenous normal saline

Placebo Comparator group

Description:

Infusion of 100 ml normal (0.9%) saline.

Treatment:

Drug: Normal saline