Healthy VolunteersPhase 1NCT01265108
Effects of Iron on Exercise Capacity During Hypoxia
A Phase 1 study testing Iron sucrose. and Normal saline in people with Healthy Volunteers, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Iron sucrose. and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Significant cardiorespiratory disease
- Known susceptibility to high altitude-related illness
- Taking medications or iron supplementation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Physiology, Anatomy & Genetics, University of Oxford
Oxford, OX1 3PT
About this study
Official title: Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.
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.
- Conditions
- Healthy Volunteers
- Being tested
- Iron sucrose., Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron sucrose.Drug
Also called Iron sucrose = Venofer
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.
Normal salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron sucrose | Experimental | Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline. Receives: Drug: Iron sucrose. |
| Intravenous normal saline | Placebo comparator | Infusion of 100 ml normal (0.9%) saline. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption.
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.
Measured: After 8-h exposure to alveolar hypoxia.
Secondary outcomes (3)
Maximal exercise capacity, assessed by peak power output.
Measured: After 8-h exposure to alveolar hypoxia.
Pulmonary artery systolic pressure.
Measured: After 8-h exposure to alveolar hypoxia.
Blood levels of oxygen-regulated proteins.
Measured: After 8-h exposure to alveolar hypoxia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick P Talbot, DPhil MRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265108
- Sponsor's protocol ID
- OHSRC-986
- Status last verified
- Jul 2015
- First submitted
- 21 Dec 2010
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans.
- ClinicalTrials.gov ID
- NCT01265108
- Acronym / sponsor ID
- OHSRC-986
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron sucrose | Experimental | Drug: Iron sucrose.Infusion of 200 mg iron sucrose (Venofer) in 100 ml normal (0.9%) saline. |
| Intravenous normal saline | Placebo comparator | Drug: Normal salineInfusion of 100 ml normal (0.9%) saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Significant cardiorespiratory disease
- Known susceptibility to high altitude-related illness
- Taking medications or iron supplementation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron sucrose.Also: Iron sucrose = VenoferVolunteers 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. | Drug | Intravenous iron sucrose |
| Normal salineVolunteers 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. | Drug | Intravenous normal saline |
Primary outcome
Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption.
Time frame: 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.
3 secondary outcomes
Maximal exercise capacity, assessed by peak power output.
Time frame: After 8-h exposure to alveolar hypoxia.
Pulmonary artery systolic pressure.
Time frame: After 8-h exposure to alveolar hypoxia.
Blood levels of oxygen-regulated proteins.
Time frame: After 8-h exposure to alveolar hypoxia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick P Talbot, DPhil MRCP principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Iron sucrose. and Normal saline in people with Healthy Volunteers, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal exercise capacity during hypoxia, assessed by maximal oxygen consumption. (time frame: After 8-h exposure to alveolar hypoxia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.