The effect of inorganic nitrite on endothelial function in ischaemia-reperfusion in the human forearm
| ISRCTN | ISRCTN57823880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57823880 |
| Protocol serial number | N0205168931 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK) |
| Funders | Barts and The London NHS Trust (UK), Queen Mary University of London (QMUL) (UK), NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 11/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A Ahluwalia
Scientific
Scientific
Barts and The London
Queen Mary's School of Medicine and Dentistry
John Vane Science Centre
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| Phone | +44 (0)20 7882 3412 |
|---|---|
| a.ahluwalia@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-blind placebo-controlled cross-over study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | The effect of inorganic nitrite on endothelial function in ischaemia-reperfusion in the human forearm |
| Study objectives | To determine whether giving additional inorganic nitrite protects the lining of the blood vessels from being damaged by an interruption in the flow of blood. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular |
| Intervention | Additional inorganic nitrite vs no additional inorganic nitrite |
| Intervention type | Other |
| Primary outcome measure(s) |
Added 27/02/2008: Reduction in forearm endothelial dysfunction (responses to acetylcholine) due to ischaemia-reperfusion with pre-ischaemic infusion of sodium nitrite |
| Key secondary outcome measure(s) |
Added 27/02/2008: Effect of nitrite on reperfusion |
| Completion date | 01/11/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | Added 27/02/2008: 1. Healthy subjects 2. Aged 18-45 3. Have volunteered themselves and are willing to sign the consent form |
| Key exclusion criteria | Added 27/02/2008: 1. Healthy subjects unwilling to consent 2. History of hypertension, diabetes or hypertensive on BP measurement 3. Pregnant or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result 4. History of any serious illnesses, including infectious diseases as above 5. Subjects taking systemic medication (other than the oral contraceptive pill) |
| Date of first enrolment | 02/08/2005 |
| Date of final enrolment | 01/11/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Barts and The London
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/10/2017: No publications found, verifying study status with principal investigator.
