The effect of gamma-tocopherol supplementation on gamma-tocopherol status, antioxidant capacity and nitrosative stress in apparently healthy smokers
| ISRCTN | ISRCTN99748080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99748080 |
| Secondary identifying numbers | 04-PG |
- Submission date
- 09/01/2008
- Registration date
- 21/02/2008
- Last edited
- 21/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Dr Julie Wallace
Scientific
Scientific
University of Ulster
Cromore Rd
Coleraine
BT52 1SA
United Kingdom
Study information
| Study design | Double-blinded randomised placebo-controlled intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The effect of gamma-tocopherol supplementation on gamma-tocopherol status, antioxidant capacity and nitrosative stress in apparently healthy smokers |
| Study objectives | Additional dietary vitamin E will help alleviate risk of cardiovascular disease in apparently healthy smokers. |
| Ethics approval(s) | University of Ulster Research Ethics Committee,13/05/2004, ref: 04/34 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 31/03/2006 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 |
| Key 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 |
| Key exclusion criteria | 1. Non-smokers 2. Pregnancy 3. Diagnosed chronic disease 4. Those who take vitamin E containing supplements or prescribed medication |
| Date of first enrolment | 31/03/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Ireland
- Northern Ireland
- United Kingdom
Study participating centre
University of Ulster
Coleraine
BT52 1SA
United Kingdom
BT52 1SA
United Kingdom
Sponsor information
SafeFood, The Food Safety Promotion Board (Ireland)
Government
Government
Cork Headquaters
7 Eastgate
Little Island
Cork
-
Ireland
| Website | http://www.safefoodonline.com |
|---|
Funders
Funder type
Government
SafeFood, The Food Safety Promotion Board (Ireland) (ref: 04-PG)
No information available
Results and Publications
| 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 |
Editorial Notes
21/03/2017: No publications found, verifying study status with principal investigator.
