Effects of Iron on Exercise Capacity During Hypoxia

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StatusasBaigta

Rėmėjai

University of Oxford

KLINIKINIS TYRIMAS: NCT01265108

BioSeek: NCT01265108

Raktažodžiai

hypoxia

Santrauka

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.

Datos

Paskutinį kartą patikrinta:	06/30/2015
Pirmasis pateikimas:	12/20/2010
Numatytas registravimas pateiktas:	12/20/2010
Pirmas paskelbtas:	12/21/2010
Paskutinis atnaujinimas pateiktas:	07/26/2015
Paskutinis atnaujinimas paskelbtas:	07/28/2015
Faktinė studijų pradžios data:	10/31/2010
Numatoma pirminio užbaigimo data:	12/31/2014
Numatoma studijų užbaigimo data:	03/31/2015

Būklė ar liga

Healthy Volunteers

Intervencija / gydymas

Drug: Intravenous iron sucrose

Drug: Intravenous normal saline

Fazė

Fazė 1

Rankų grupės

Ranka	Intervencija / gydymas
Experimental: Intravenous iron sucrose Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline.	Drug: Intravenous 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.
Placebo Comparator: Intravenous normal saline Infusion of 100 ml normal (0.9%) saline.	Drug: Intravenous 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.

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	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

Rezultatas

Pirminės rezultatų priemonės

1. Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption. [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.

Antrinės rezultatų priemonės

1. Maximal exercise capacity, assessed by peak power output. [After 8-h exposure to alveolar hypoxia.]

2. Pulmonary artery systolic pressure. [After 8-h exposure to alveolar hypoxia.]

3. Blood levels of oxygen-regulated proteins. [After 8-h exposure to alveolar hypoxia]