Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/01/2009
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 PMS O'Brien

ORCID ID

Contact details

Obstetrics and Gynaecology Academic Department
Maternity Block
City General
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
+44 (0)1782 554998

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0158024607

Study information

Scientific title

Acronym

Study hypothesis

To determine the effect of fish oil dietary supplements and aspirin on platelet angiotensin II binding.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular: Hypertension

Intervention

Normotensive and hypertensive women will be randomly allocated in a double blind manner to one of the four groups: fish oil, aspirin, fish oil and aspirin and placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

fish oil, aspirin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1994

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

128 women in total will be recruited, 32 patients to each of the four treatment arms. Half the women will be hypertensive and the other half normotensive.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

128

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/1994

Recruitment end date

01/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Obstetrics and Gynaecology Academic Department
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

North Staffordshire Research and Development Consortium (UK)

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

1999 results in http://www.ncbi.nlm.nih.gov/pubmed/15512224

Publication citations

  1. Results

    Walker T, Singh PK, Wyatt KM, O'Brien PM, The effect of prostanoid precursors and inhibitors on platelet angiotensin II binding., J Obstet Gynaecol, 1999, 19, 1, 56-58, doi: 10.1080/01443619965985.

Additional files

Editorial Notes