Impact of Iron Supplementation on Right Ventricular Function and Exercise Performance in Hypoxia
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Colorado, Denver
About this trial
The purpose of this study is to determine if taking iron supplement pills improves exercise performance in low-oxygen conditions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 - 60
For women, premenopausal status
Disqualifiers
Active cardiovascular or pulmonary disease (e.g. hypertension, coronary artery disease, cardiomyopathy, arrhythmia, valvular abnormalities, diabetes, peripheral vascular disease, tobacco use, chronic obstructive pulmonary disease, asthma, interstitial lung disease, restrictive lung disease, or pulmonary hypertension)
Use of cardiac- or pulmonary-related medications
Prior history of high altitude pulmonary edema or high altitude cerebral edema
Body mass index < 18.5 or > 30
Trial design
Design model
Crossover
Treatments tested in this trial
Ferrous sulfate 325mg
DrugParticipants will take one tab of ferrous sulfate 325 mg (equivalent to 65 mg elemental iron) daily for 30 days.
Treatment groups
5 Participants
are divided into 2 treatment groupsGroup A: Healthy individuals - pre-ironPlacebo comparator 1 intervention
Group B: Healthy individuals - post-ironActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximum workload
Workload in Watts at peak exercise on upright cycle ergometer
Time frame
Up to 1 hour2
Maximal oxygen uptake
Maximal oxygen uptake at peak exercise (VO2max) in L/min
Time frame
Up to 1 hourSecondary outcomes
1
Oxygen saturation at peak exercise
Peripheral oxygen saturation (SpO2)
Time frame
Up to 1 hour2
Submaximal Stage 1 workload
Workload in Watts at 40% x hypoxic VO2max (obtained during baseline hypoxic exercise test)
Time frame
Up to 1 hour3
Submaximal Stage 2 workload
Workload in Watts at 60% x hypoxic VO2max (obtained during baseline hypoxic exercise test)
Time frame
Up to 1 hour4
Ventilatory threshold
Oxygen uptake (VO2 in L/min) at which slope of VCO2/VO2 relationship increases
Time frame
Up to 1 hourSponsors and contacts
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Source ClinicalTrials.gov
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