Condition category
Circulatory System
Date applied
09/01/2008
Date assigned
21/02/2008
Last edited
01/07/2014
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 Julie Wallace

ORCID ID

Contact details

University of Ulster
Cromore Rd
Coleraine
BT52 1SA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04-PG

Study information

Scientific title

Acronym

Study hypothesis

We hypothesise that additional dietary vitamin E will help alleviate risk of cardiovascular disease in apparently healthy smokers.

Ethics approval

University of Ulster Research Ethics Committee,13/05/2004, ref: 04/34

Study design

Double-blinded randomised placebo-controlled intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular risk

Intervention

Oral supplementation of 100 mg of gamma-tocopherol or a placebo. Supplementation is provided for 6 months. There is no further follow-up after the post-intervention samples are collected.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin E

Primary outcome measures

1. Tocopherol concentrations
2. Selenium concentrations
3. Inflammation markers

All primary outcome measures are assessed when samples are collected at baseline, month 3 and month 6.

Secondary outcome measures

1. Body composition measurements
2. Immune markers

All secondary outcome measures are assessed at baseline and month 6.

Overall trial start date

31/03/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consenting adult men and women
2. Smoke five or more cigarettes per day
3. Between 18 and 50 years of age
4. In general good health

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Non-smokers
2. Pregnancy
3. Diagnosed chronic disease
4. Those who take vitamin E containing supplements or prescribed medication

Recruitment start date

31/03/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

University of Ulster
Coleraine
BT52 1SA
United Kingdom

Sponsor information

Organisation

SafeFood, The Food Safety Promotion Board (Ireland)

Sponsor details

Cork Headquaters
7 Eastgate
Little Island
Cork
-
Ireland

Sponsor type

Government

Website

http://www.safefoodonline.com

Funders

Funder type

Government

Funder name

SafeFood, The Food Safety Promotion Board (Ireland) (ref: 04-PG)

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