Coronary Artery DiseasePhase 4NCT02011906
The Effects of Omega 3 and Vitamin E Supplementation on the Serum Antioxidant Enzymes and Gene Expressions of PGC-1a, h TERT, FOXOs and SIRTs in CAD Patients
A Phase 4 study testing omega 3 and vitamin E in people with Coronary Artery Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to determine the effects of omega 3 supplementation and its concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in the patients with coronary artery disease Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- omega 3 and vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Oct 2013to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- literate, willingness to participation, CAD patients 45- 65 years old, body mass index< 30, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willing to maintain body weight during the study
Who cannot join
- people who have used vitamin E or omega 3 supplements in last 3 months, having chronic renal disease ,cancer, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, diabetes, treatment with PPAR-gamma agonists or Thiazolidinediones, Smokers
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the effects of omega 3 supplementation and its concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in the patients with coronary artery disease
- Conditions
- Coronary Artery Disease
- Being tested
- omega 3, vitamin E, placebo of omega 3, placebo of vitamin E
- Keywords
- antioxidant enzymes, omega 3, vitamin E, CAD, Sirtuins, FOXOs
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3Dietary supplement
vitamin EDietary supplement
placebo of omega 3Dietary supplement
placebo of vitamin EDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| CAD, OMEGA 3 | Active comparator | patients with CAD who receive 4 gr/day omega 3 in the form of 4 softgels each of them contains 1000 mg omega 3 and a softgel contains placebo of vitamin E Receives: Dietary Supplement: omega 3; Dietary Supplement: placebo of vitamin E |
| CAD, omega 3 and vitamin E | Active comparator | patients with CAD who receive 4 gr/day omega 3 in the form of 4 softgels each of them contains 1000 mg omega 3 and a softgel contains 400 IU vitamin E Receives: Dietary Supplement: omega 3; Dietary Supplement: vitamin E |
| CAD, placebo | Placebo comparator | patients with CAD who receive 4 softgels/day each of them contains placebo of omega 3 and a softgel/day contains placebo of vitamin E Receives: Dietary Supplement: placebo of omega 3; Dietary Supplement: placebo of vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum total cholesterol
Measured: change from baseline at 2 months
serum HDL cholesterol
Measured: change from baseline at 2 months
serum triglycerides level
Measured: change from baseline at 2 months
serum LDL cholesterol
Measured: change from baseline at 2 months
serum insulin
Measured: change from baseline at 2 months
serum Hs-CRP
Measured: change from baseline at 2 months
serum gluthatione peroxidase
Measured: change from baseline at 2 months
serum catalase
Measured: change from baseline at 2 months
serum superoxide dismutase
Measured: change from baseline at 2 months
serum total antioxidant capacity
Measured: change from baseline at 2 months
Secondary outcomes (7)
gene expression of SIRT1
Measured: change from baseline at 2 months
gene expression of SIRT3
Measured: change from baseline at 2 months
gene expression of SIRT6
Measured: change from baseline at 2 months
gene expression of PGC-1a
Measured: change from baseline at 2 months
gene expression of FOXO3a
Measured: change from baseline at 2 months
gene expression of FOXO1
Measured: change from baseline at 2 months
gene expression of h TERT
Measured: change from baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011906
- Sponsor's protocol ID
- 95983
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Omega 3 and Vitamin E Supplementation on the Serum Antioxidant Enzymes and Gene Expressions of PGC-1a, h TERT, FOXOs and SIRTs in CAD Patients
- ClinicalTrials.gov ID
- NCT02011906
- Acronym / sponsor ID
- 95983
- Conditions
- Coronary Artery Disease
- Keywords
- antioxidant enzymes, omega 3, vitamin E, CAD, Sirtuins, FOXOs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effects of omega 3 supplementation and its concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in the patients with coronary artery disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAD, OMEGA 3 | Active comparator | Dietary Supplement: omega 3, Dietary Supplement: placebo of vitamin Epatients with CAD who receive 4 gr/day omega 3 in the form of 4 softgels each of them contains 1000 mg omega 3 and a softgel contains placebo of vitamin E |
| CAD, omega 3 and vitamin E | Active comparator | Dietary Supplement: omega 3, Dietary Supplement: vitamin Epatients with CAD who receive 4 gr/day omega 3 in the form of 4 softgels each of them contains 1000 mg omega 3 and a softgel contains 400 IU vitamin E |
| CAD, placebo | Placebo comparator | Dietary Supplement: placebo of omega 3, Dietary Supplement: placebo of vitamin Epatients with CAD who receive 4 softgels/day each of them contains placebo of omega 3 and a softgel/day contains placebo of vitamin E |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -
- literate, willingness to participation, CAD patients 45- 65 years old, body mass index< 30, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willing to maintain body weight during the study
Key exclusion criteria (1 listed)
- people who have used vitamin E or omega 3 supplements in last 3 months, having chronic renal disease ,cancer, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, diabetes, treatment with PPAR-gamma agonists or Thiazolidinediones, Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega 3 | Dietary supplement | CAD, OMEGA 3, CAD, omega 3 and vitamin E |
| vitamin E | Dietary supplement | CAD, omega 3 and vitamin E |
| placebo of omega 3 | Dietary supplement | CAD, placebo |
| placebo of vitamin E | Dietary supplement | CAD, OMEGA 3, CAD, placebo |
Primary outcome
serum total cholesterol
Time frame: change from baseline at 2 months
serum HDL cholesterol
Time frame: change from baseline at 2 months
serum triglycerides level
Time frame: change from baseline at 2 months
serum LDL cholesterol
Time frame: change from baseline at 2 months
serum insulin
Time frame: change from baseline at 2 months
serum Hs-CRP
Time frame: change from baseline at 2 months
serum gluthatione peroxidase
Time frame: change from baseline at 2 months
serum catalase
Time frame: change from baseline at 2 months
serum superoxide dismutase
Time frame: change from baseline at 2 months
serum total antioxidant capacity
Time frame: change from baseline at 2 months
7 secondary outcomes
gene expression of SIRT1
Time frame: change from baseline at 2 months
gene expression of SIRT3
Time frame: change from baseline at 2 months
gene expression of SIRT6
Time frame: change from baseline at 2 months
gene expression of PGC-1a
Time frame: change from baseline at 2 months
gene expression of FOXO3a
Time frame: change from baseline at 2 months
gene expression of FOXO1
Time frame: change from baseline at 2 months
gene expression of h TERT
Time frame: change from baseline at 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omega 3 and vitamin E in people with Coronary Artery Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum total cholesterol (time frame: change from baseline at 2 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.