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Iron Status and Cardiopulmonary Physiology

NCT03707249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-10-18

No results posted yet for this study

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.

Conditions

  • Iron-deficiency
  • Ventricular Function
  • Pulmonary Vascular Resistance Abnormality
  • Altitude Hypoxia

Interventions

DRUG

Ferric Carboxymaltose Injectable Product

iv iron infusion: 15 mg / kg up to a maximum 1g dose of Ferinject diluted in normal saline (0.9%) up to a total volume of 250 ml

DRUG

Normal Saline 0.9% Infusion Solution Bag

250 ml of normal (0.9%) saline given by intravenous infusion over 20 minutes. This constitutes the control for the iron infusion.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Royal Centre for Defence Medicine

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-19
Primary Completion
2016-05-01
Completion
2017-12-07

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03707249 on ClinicalTrials.gov