Iron Status and Cardiopulmonary Physiology

• Status: Completed
• Trial end date: 2017-12-07
• Target enrollment: 0
• Participant gender: All

Summary

This study involved human volunteers undertaking a high-altitude expedition. It assessed changes in physiological parameters of relevance to high-altitude cardiopulmonary physiology. Participants included a subgroup of those taking part in an existing adventurous training expedition and were randomised in a 1:1 fashion to receive either intravenous iron or normal saline several weeks prior to departure. During the expedition, participants were investigated by means of transthoracic echocardiography, peripheral oxygen saturation measurement and heart rate monitoring and through the drawing of venous blood samples. Bloods were later analysed for markers of iron status.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Royal Centre for Defence Medicine
• Collaborator: University of Oxford
• Treatments: Ferric Compounds; Iron

Criteria

Inclusion Criteria:

• Healthy non-pregnant adults

• Age 18-55 years

• Serving in the UK Armed Forces

• Selected for a military mountaineering team intending to climb to very high altitude

Exclusion Criteria:

• Diabetes

• Any cardiovascular or respiratory illness

• Regular medication which would interfere with any outcome measures in the study

• Pregnancy

• Any condition which precludes the administration of Ferinject:

(i) hypersensitivity to the active substance, to Ferinject® or any of its excipients (ii) known serious hypersensitivity to other parenteral iron products (iii) microcytic anaemia not attributable to iron deficiency (e.g. sickle cell anaemia) (iv) evidence of iron overload or disturbances in the utilisation of iron.