Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
18/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Ahluwalia

ORCID ID

Contact details

Barts and The London
Queen Mary's School of Medicine and Dentistry
John Vane Science Centre
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 020 7882 3412
a.ahluwalia@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205168931

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised single-blind placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular

Intervention

Additional inorganic nitrite vs no additional inorganic nitrite

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 trial start date

02/08/2005

Overall trial end date

01/11/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant 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)

Recruitment start date

02/08/2005

Recruitment end date

01/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts and The London
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Queen Mary University of London (QMUL) (UK)

Alternative name(s)

QMUL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes