ISRCTN ISRCTN85634342
DOI https://doi.org/10.1186/ISRCTN85634342
Protocol serial number N0158024607
Sponsor Department of Health (UK)
Funder North Staffordshire Research and Development Consortium (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
15/01/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr PMS O'Brien
Scientific

Obstetrics and Gynaecology Academic Department
Maternity Block
City General
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Phone +44 (0)1782 554998

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo determine the effect of fish oil dietary supplements and aspirin on platelet angiotensin II binding.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Hypertension
InterventionNormotensive 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 typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)fish oil, aspirin
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/06/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration128
Key inclusion criteria128 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/06/1994
Date of final enrolment01/06/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/1999 Yes No