Rheumatoid ArthritisPhase 1NCT00399282
Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis
A Phase 1 study testing Omega-3 and Vitamin E supplementation in people with Rheumatoid Arthritis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Omega-3 and Vitamin E supplementation
- How many people
- 75 participants
- Where
- 1 siteIran
- Study dates
- Oct 2006to Apr 2007
- Phase
- Phase 1
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of rheumatoid arthritis according American college of rheumatology (ACR)
Who cannot join
- Infection
- Major joint malformations
- Simultaneous diseases like metabolic and gastrointestinal
- Being class IV according to ACR
- Drug dose fluctuations
- History of Vit E and/or omega-3 supplements during past six months
- Gastric irrigations
Trial locations and contacts
1 site in 1 country.
Iran1 site
Rheumatology Research Center (RRC), Tehran University for medical Sciences (TUMS)
Tehran
About this study
Official title: Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis
The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.
Read the detailed description
The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.
Most of studies on omega-3 fatty acids (omega-3) supplementation in patients with rheumatoid arthritis (RA) have clearly shown potentially beneficial changes in cytokine and eicosanoid metabolism. The overall clinical improvement, however, has been only moderate. One explanation is that an increased intake of omega-3 leads to a reduction in the availability of antioxidants and an increased generation of lipid peroxides. The majority of the anti-inflammatory drugs routinely used nowadays are COX (cyclo-oxygenase) inhibitors. Mechanism of COX II inhibitors is similar of omega-3. So, it is difficult to differentiate omega-3 net effects in some situations. Existing clinical trials on omega-3 and vitamin E (Vit E) are sometimes questioned due to using omega-6 fatty acids as placebo and neglecting omega-6 fatty acid intake in the diet. A comprehensive randomized controlled double-blind trial would have omega-6 fatty acids served as placebo in patients who are well matched in terms of therapies and drugs.
Comparison(s): Comparison of groups supplemented with omega-3, omega-3 with Vit E, and placebo (Medium chain triglycerides: MCT).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Omega-3 and Vitamin E supplementation
- Keywords
- Rheumatoid arthritis, Health related quality of life, Omega 3 fatty acids, Vitamin E
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 and Vitamin E supplementationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Persian version of health assessment questionnaire (PE-HAQ) at 0, 6 and 12 weeks
Disease activity score at 0, 6 and 12 weeks
Duration of morning stiffness (in minutes) at 0, 6 and 12 weeks
Joint pain intensity, on a five-point scale (0, absent) at 0, 6 and 12 weeks
Onset of fatigue (in minutes) after walking at 0, 6 and 12 weeks
Ritchie's articular index for pain joints at 0, 6 and 12 weeks
Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at 0, 6 and 12 weeks
Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at 0, 6 and 12 weeks
Classification of functional status in RA according to revised criteria of the American
College of Rheumatology at 0, 6 and 12 weeks
Patient's satisfaction in activities of daily living based on a Persian version of Health Assessment Questionnaire (PE-HAQ) at 0, 6 and 12 weeks
Secondary outcomes (7)
TNF-alpha at 0, 6 and 12 weeks
IL-1 beta at 0, 6 and 12 weeks
C-reactive protein at 0, 6 and 12 weeks
Erythrocyte sedimentation rate at 0, 6 and 12 weeks
Malondialdehyde at 0, 6 and 12 weeks
Systolic blood pressure at 0, 6 and 12 weeks
Diastolic blood pressure at 0, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startOct 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Reza Rastmanesh, Ph.D., Principal investigator, National Nutrition and Food Sciences Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399282
- Sponsor's protocol ID
- NNFTRI-2484
- Status last verified
- Apr 2007
- First submitted
- 13 Nov 2006
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00399282
- Acronym / sponsor ID
- NNFTRI-2484
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Health related quality of life, Omega 3 fatty acids, Vitamin E
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 14 Nov 2006 (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 purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.
Detailed description
The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.
Most of studies on omega-3 fatty acids (omega-3) supplementation in patients with rheumatoid arthritis (RA) have clearly shown potentially beneficial changes in cytokine and eicosanoid metabolism. The overall clinical improvement, however, has been only moderate. One explanation is that an increased intake of omega-3 leads to a reduction in the availability of antioxidants and an increased generation of lipid peroxides. The majority of the anti-inflammatory drugs routinely used nowadays are COX (cyclo-oxygenase) inhibitors. Mechanism of COX II inhibitors is similar of omega-3. So, it is difficult to differentiate omega-3 net effects in some situations. Existing clinical trials on omega-3 and vitamin E (Vit E) are sometimes questioned due to using omega-6 fatty acids as placebo and neglecting omega-6 fatty acid intake in the diet. A comprehensive randomized controlled double-blind trial would have omega-6 fatty acids served as placebo in patients who are well matched in terms of therapies and drugs.
Comparison(s): Comparison of groups supplemented with omega-3, omega-3 with Vit E, and placebo (Medium chain triglycerides: MCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of rheumatoid arthritis according American college of rheumatology (ACR)
Key exclusion criteria (7 listed)
- Infection
- Major joint malformations
- Simultaneous diseases like metabolic and gastrointestinal
- Being class IV according to ACR
- Drug dose fluctuations
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 and Vitamin E supplementation | Drug | – |
Primary outcome
Score on Persian version of health assessment questionnaire (PE-HAQ) at 0, 6 and 12 weeks
Disease activity score at 0, 6 and 12 weeks
Duration of morning stiffness (in minutes) at 0, 6 and 12 weeks
Joint pain intensity, on a five-point scale (0, absent) at 0, 6 and 12 weeks
Onset of fatigue (in minutes) after walking at 0, 6 and 12 weeks
Ritchie's articular index for pain joints at 0, 6 and 12 weeks
Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at 0, 6 and 12 weeks
Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at 0, 6 and 12 weeks
Classification of functional status in RA according to revised criteria of the American
College of Rheumatology at 0, 6 and 12 weeks
Patient's satisfaction in activities of daily living based on a Persian version of Health Assessment Questionnaire (PE-HAQ) at 0, 6 and 12 weeks
7 secondary outcomes
TNF-alpha at 0, 6 and 12 weeks
IL-1 beta at 0, 6 and 12 weeks
C-reactive protein at 0, 6 and 12 weeks
Erythrocyte sedimentation rate at 0, 6 and 12 weeks
Malondialdehyde at 0, 6 and 12 weeks
Systolic blood pressure at 0, 6 and 12 weeks
Diastolic blood pressure at 0, 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2007.
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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.
Reza Rastmanesh, Ph.D. principal investigator
National Nutrition and Food Sciences Technology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega-3 and Vitamin E supplementation in people with Rheumatoid Arthritis, run by Shahid Beheshti 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 18 Apr 2007. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score on Persian version of health assessment questionnaire (PE-HAQ) at 0, 6 and 12 weeks. The study lists 11 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 18 Apr 2007.