Healthy VolunteersPhase 1NCT03077763
The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation
A Phase 1 study testing Sodium Nitrite in people with Healthy Volunteers, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
The study is a pharmacodynamic random order cross-over trial investigating the physiological effects of intra-arterial infusion of nitrite following a haemolysed autologous blood transfusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sodium Nitrite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Mar 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged greater than or equal to 18 years
- If between 18-20 years of age, calculate total blood volume should be more than >3.5L (http://www.blood.co.uk/giving-blood/who-can-give-blood/)
- Body weight > 50kg weight (8 stone 12lbs)
- Not known to have any significant past medical history and not having regular follow up (Check Donor Selection Guidelines (http://www.transfusionguidelines.org.uk/)
- Willing to provide blood donation and receive autologous blood transfusion
- After assessment for eligibility pass all blood donor eligibility criteria
- Able to provide informed consent
- Should inform overseas travel plan during study period (Check Geographical Disease Risk Index on http://www.transfusionguidelines.org.uk/dsg/gdri) e.g. unable to donate blood for 6 months if travel in a malaria endemic country. Similar guidelines for West Nile virus and T. Cruzi endemic countries.
Who cannot join
- Significant medical, surgical or psychiatric disease that in the opinion of the Clinical Research Fellow would affect subject safety or significantly impact his/her ability to comply with follow-up. This would include any known clotting disorders.
- Known allergy or intolerance to Nitrites
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Female subjects must be of non-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
- Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the drug half-life, whichever is the longer
- Predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease.
- No past history of significant adverse events post blood donation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of East Anglia
Norwich, Norfolk, NR4 7UQ
Nicholas D Gollop, MRCP, 01603 591790 ext. 1790, n.gollop@uea.ac.uk
About this study
Official title: The Effects of Free Haemoglobin NO-blockade on Nitrite Forearm Vessel Dilatation Under Normoxia and Hypoxia in Healthy Volunteers
The study is a pharmacodynamic random order cross-over trial investigating the physiological effects of intra-arterial infusion of nitrite following a haemolysed autologous blood transfusion.
Read the detailed description
This is a healthy volunteer study.
Following entry into this cross-over trial, participants will be randomized to undergo experiments under either normoxic followed by hypoxic conditions, or hypoxic followed by normoxic conditions.
Subjects will donate whole blood as an autologous unit at a preselected NHSBT donation site. The unit will transported back to the NNUH blood bank after a minimum of 30 days (maximum 35 days) after donation.
Volunteers will be tested for baseline bloods. Volunteers will be randomised to normoxia or hypoxia. The will then undergo a nitrite infusion, followed by an autologous whole blood transfusion and a second nitrite infusion (which will co-infuse at the end of the transfusion). During the protocol, the participants will undergo repeated FBFR measurements using strain-gauge plethysmography.
After a minimum of 12 weeks rest period after their initial donation, participants will cross-over to the opposite oxygen condition (as per initial randomization) and the above protocol will be repeated. All interventions will be performed by fully trained and competent medical staff.
- Conditions
- Healthy Volunteers
- Being tested
- Sodium Nitrite
- Keywords
- nitrite, haemoglobin, normoxia, hypoxia, vasodilatation, blood
- Medical subject headings
- Hypoxia, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NitriteDrug
| Study group | Role | What they receive |
|---|---|---|
| Normoxia and Nitrite (3umol/min-1) | Active comparator | Sodium nitrite stock solution: 100umol/10ml, prepared to concentration according to oxygen sequence. Normoxia (3umol/min-1). Receives: Drug: Sodium Nitrite |
| Hypoxia and Nitrite (1umol/min-1) | Active comparator | This will be repeated as per the normoxia cohort, but at a reduced dose of sodium nitrite (1umol/min-1 for 30 minutes) and the volunteers will be asked to breathe 12% oxygen/88% nitrogen for 1-5 minutes before Plethysmography is performed (to get the volunteer to an oxygen saturation of 83-88% peripherally). Receives: Drug: Sodium Nitrite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FBFR during intra-brachial nitrite and haemolysed blood co-infusion in normoxia vs hypoxia.
Measured: Up to 18 months
Secondary outcomes (5)
Change in FBFR during haemolysed blood infusion vs baseline
Measured: Up to 18 months
Change in FBFR during nitrite infusion in normoxia vs nitrite infusion in hypoxia
Measured: Up to 18 months
Change in FBFR during nitrite infusion in normoxia vs baseline
Measured: Up to 18 months
Change in FBFR during nitrite infusion in hypoxia vs baseline
Measured: Up to 18 months
Blood analysis (cell free haemoglobin, nitrate, nitrite and nitroso species levels)
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startDec 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael P Frenneaux, FRCP, FESC, Principal investigator, Dean of Medicine, Norwich Medical School, The University of East Anglia, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077763
- Sponsor's protocol ID
- 206995
- Status last verified
- Mar 2017
- First submitted
- 20 Sep 2016
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Free Haemoglobin NO-blockade on Nitrite Forearm Vessel Dilatation Under Normoxia and Hypoxia in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03077763
- Acronym / sponsor ID
- 206995
- Conditions
- Healthy Volunteers
- Keywords
- nitrite, haemoglobin, normoxia, hypoxia, vasodilatation, blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 13 Mar 2017 (actual)
- 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.
The study is a pharmacodynamic random order cross-over trial investigating the physiological effects of intra-arterial infusion of nitrite following a haemolysed autologous blood transfusion.
Detailed description
This is a healthy volunteer study.
Following entry into this cross-over trial, participants will be randomized to undergo experiments under either normoxic followed by hypoxic conditions, or hypoxic followed by normoxic conditions.
Subjects will donate whole blood as an autologous unit at a preselected NHSBT donation site. The unit will transported back to the NNUH blood bank after a minimum of 30 days (maximum 35 days) after donation.
Volunteers will be tested for baseline bloods. Volunteers will be randomised to normoxia or hypoxia. The will then undergo a nitrite infusion, followed by an autologous whole blood transfusion and a second nitrite infusion (which will co-infuse at the end of the transfusion). During the protocol, the participants will undergo repeated FBFR measurements using strain-gauge plethysmography.
After a minimum of 12 weeks rest period after their initial donation, participants will cross-over to the opposite oxygen condition (as per initial randomization) and the above protocol will be repeated. All interventions will be performed by fully trained and competent medical staff.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normoxia and Nitrite (3umol/min-1) | Active comparator | Drug: Sodium NitriteSodium nitrite stock solution: 100umol/10ml, prepared to concentration according to oxygen sequence. Normoxia (3umol/min-1). |
| Hypoxia and Nitrite (1umol/min-1) | Active comparator | Drug: Sodium NitriteThis will be repeated as per the normoxia cohort, but at a reduced dose of sodium nitrite (1umol/min-1 for 30 minutes) and the volunteers will be asked to breathe 12% oxygen/88% nitrogen for 1-5 minutes before Plethysmography is performed (to get the volunteer to an oxygen saturation of 83-88% peripherally). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged greater than or equal to 18 years
- If between 18-20 years of age, calculate total blood volume should be more than >3.5L (http://www.blood.co.uk/giving-blood/who-can-give-blood/)
- Body weight > 50kg weight (8 stone 12lbs)
- Not known to have any significant past medical history and not having regular follow up (Check Donor Selection Guidelines (http://www.transfusionguidelines.org.uk/)
- Willing to provide blood donation and receive autologous blood transfusion
Key exclusion criteria (7 listed)
- Significant medical, surgical or psychiatric disease that in the opinion of the Clinical Research Fellow would affect subject safety or significantly impact his/her ability to comply with follow-up. This would include any known clotting disorders.
- Known allergy or intolerance to Nitrites
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Female subjects must be of non-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
- Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the drug half-life, whichever is the longer
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 |
|---|---|---|
| Sodium Nitrite | Drug | Hypoxia and Nitrite (1umol/min-1), Normoxia and Nitrite (3umol/min-1) |
Primary outcome
Change in FBFR during intra-brachial nitrite and haemolysed blood co-infusion in normoxia vs hypoxia.
Time frame: Up to 18 months
5 secondary outcomes
Change in FBFR during haemolysed blood infusion vs baseline
Time frame: Up to 18 months
Change in FBFR during nitrite infusion in normoxia vs nitrite infusion in hypoxia
Time frame: Up to 18 months
Change in FBFR during nitrite infusion in normoxia vs baseline
Time frame: Up to 18 months
Change in FBFR during nitrite infusion in hypoxia vs baseline
Time frame: Up to 18 months
Blood analysis (cell free haemoglobin, nitrate, nitrite and nitroso species levels)
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Individual participant dataSharing planned: No
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Screening Protocol
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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.
Michael P Frenneaux, FRCP, FESC principal investigator
Dean of Medicine, Norwich Medical School, The University of East Anglia, UK
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 Sodium Nitrite in people with Healthy Volunteers, run by University of East Anglia 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Mar 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas D Gollop, MRCP(UK) (01603 591790 ext. 1790, n.gollop@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FBFR during intra-brachial nitrite and haemolysed blood co-infusion in normoxia vs hypoxia. (time frame: Up to 18 months). 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 20 Mar 2017.