The effect of inorganic nitrite on endothelial function in ischaemia-reperfusion in the human forearm

ISRCTN	ISRCTN57823880
DOI	https://doi.org/10.1186/ISRCTN57823880
Secondary identifying numbers	N0205168931

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

Dr A Ahluwalia
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
Email	a.ahluwalia@qmul.ac.uk

Study design	Randomised single-blind placebo-controlled cross-over study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	Added 27/02/2008: Reduction in forearm endothelial dysfunction (responses to acetylcholine) due to ischaemia-reperfusion with pre-ischaemic infusion of sodium nitrite
Secondary outcome measures	Added 27/02/2008: Effect of nitrite on reperfusion
Overall study start date	02/08/2005
Completion date	01/11/2012

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Both
Target number of participants	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

Barts and The London

London
EC1M 6BQ
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Barts and The London NHS Trust (UK)

No information available

Queen Mary University of London (QMUL) (UK)
Private sector organisation / Universities (academic only)

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

11/10/2017: No publications found, verifying study status with principal investigator.