Effects of Iron on Exercise Capacity During Hypoxia

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University of Oxford

KLINIK ÇALIŞMA: NCT01265108

BioSeek: NCT01265108

Anahtar kelimeler

hipoksi

Öz

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.

Tarih

Son Doğrulandı:	06/30/2015
İlk Gönderilen:	12/20/2010
Tahmini Kayıt Gönderildi:	12/20/2010
İlk Gönderilen:	12/21/2010
Son Güncelleme Gönderildi:	07/26/2015
Son Güncelleme Gönderildi:	07/28/2015
Fiili Çalışma Başlangıç Tarihi:	10/31/2010
Tahmini Birincil Tamamlanma Tarihi:	12/31/2014
Tahmini Çalışma Tamamlanma Tarihi:	03/31/2015

Durum veya hastalık

Healthy Volunteers

Müdahale / tedavi

Drug: Intravenous iron sucrose

Drug: Intravenous normal saline

Evre

Evre 1

Kol Grupları

Kol	Müdahale / tedavi
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.

Uygunluk kriterleri

Çalışmaya Uygun Yaşlar	18 Years İçin 18 Years
Çalışmaya Uygun Cinsiyetler	All
Sağlıklı Gönüllüleri Kabul Ediyor	Evet
Kriterler	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

Sonuç

Birincil Sonuç Ölçütleri

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.

İkincil Sonuç Ölçütleri

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]