Rheumatoid ArthritisPhase 3NCT00072982
Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
A Phase 3 study testing fish oil, borage seed oil and combination fish oil and borage seed oil in people with Rheumatoid Arthritis, run by National Center for Complementary and Integrative Health (NCCIH) at 13 sites in United States.
Trial summary
The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- fish oil, borage seed oil and combination fish oil and borage seed oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 13 sitesUnited States
- Study dates
- Nov 2006to Nov 2008
- Phase
- Phase 3
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite RA with onset at > 16 years, with total disease duration of at least 6 months
- Active disease as manifested by at least 3 joints that are swollen and 6 joints that are tender at time of enrollment, and either an erythrocyte sedimentation rate >_28, or a CRP >1.4, or morning stiffness of at least 45 min
- Stable dose of DMARDs for 2 mos before baseline visit, with total duration of DMARD for 6 mos.
- All standard therapy for RA, including DMARDs and combinations of DMARDs will be allowed as long as doses have been stable for 2 mos
- Stable NSAID for 1 month before baseline if on an NSAID
- Stable prednisone dose of < 10 mg/day for 1 month before baseline visit, if on prednisone
Show all 9Show fewer
- Ability to give and understand all elements of informed consent
- Absence of comorbid condition which, in the opinion of the physician-investigator, would render the patient unsuitable for the study
- Willingness to adhere to the clinical protocol.
Who cannot join
- A diagnosis of inflammatory arthritis other than rheumatoid arthritis
- Chronic anticoagulation
- Hypersensitivity to fish or fish products or plant products
- A dose of prednisone of > 10 mg/day, or either a change in the prednisone dose or intra-articular corticosteroid injection within one month of the baseline evaluation
- An inability or unwillingness to use an effective form of contraception (females) during the duration of the study
- Pregnant and breast-feeding females
Show all 10Show fewer
- Inability or unwillingness to adhere to the study diet
- Platelet count < 100,000/mm 3
- Hemoglobin < 9 g/dl
- Albumin < 3.3 g
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Joel M. Kremer
Albany, New York, 12206
UAB Arthritis Clinical Intervention Program
Birmingham, Alabama, 35297
RASF Clinical Research Center
Boca Raton, Florida, 33486
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania, 19010
Geisinger Medical Center
Danville, Pennsylvania, 17822
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Piedmont Arthritis Clinic
Greenville, South Carolina, 29601
Prem Tambar, MD
Niagara Falls, New York, 14303
Rheumatology and Internal Medicine Associates of West County, PC
St Louis, Missouri, 63131
Lake Rheumatology
Tavares, Florida, 32778
New England Res. Associates
Trumbull, Connecticut, 06611
Fallon Clinic Health Care
Worcester, Massachusetts, 01605
Division of Rheumatology, Umass Memorial Health Care
Worcester, Massachusetts, 01655
About this study
The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. This study will also investigate the biochemical, immunological, and molecular mechanism responsible for the therapeutic effects of these fatty acids. Each patient will be followed for eighteen months.
Read the detailed description
See Brief Summary
- Conditions
- Rheumatoid Arthritis
- Being tested
- fish oil, borage seed oil, combination fish oil and borage seed oil
- Keywords
- Fish oil, Borage oil
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDrug
Also called EPA
The object of this intervention is to determine whether treatment of rheumatoid arthritis with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. Each arm of the study will take 13 capsules daily (divided doses) for 18 months.
borage seed oilDrug
Also called GLA
Borage oil 13 capsules divided doses daily for 18 months
combination fish oil and borage seed oilDrug
Also called EPA and GLA
Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fish Oil Receives: Drug: fish oil |
| 2 | Active comparator | Borage Oil Receives: Drug: borage seed oil |
| 3 | Active comparator | Fish Oil and Borage Oil Receives: Drug: combination fish oil and borage seed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Disease Activity Score (DAS28) will be the primary outcome measure.
Measured: Assessed every 3 months
Secondary outcomes (1)
Reduction of other medication for RA
Measured: Assessed every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2003 (estimated)
- Study startNov 2006
- Primary completionMay 2008
- Study completionNov 2008 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert B Zurier, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072982
- Sponsor's protocol ID
- R01AT000309-01A2
- Other IDs
- NIH RO1 AT000309-01A2, UMASS IRB Docket #10225, NEIRB Docket #04-039, FDA IND #69,292
- Status last verified
- Aug 2008
- First submitted
- 13 Nov 2003
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
- ClinicalTrials.gov ID
- NCT00072982
- Acronym / sponsor ID
- R01AT000309-01A2
- Conditions
- Rheumatoid Arthritis
- Keywords
- Fish oil, Borage oil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Nov 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Nov 2008 (estimated)
- First posted
- 17 Nov 2003 (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 object of this study is to determine whether treatment of rheumatoid arthritis (RA) with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. This study will also investigate the biochemical, immunological, and molecular mechanism responsible for the therapeutic effects of these fatty acids. Each patient will be followed for eighteen months.
Detailed description
See Brief Summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: fish oilFish Oil |
| 2 | Active comparator | Drug: borage seed oilBorage Oil |
| 3 | Active comparator | Drug: combination fish oil and borage seed oilFish Oil and Borage Oil |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Definite RA with onset at > 16 years, with total disease duration of at least 6 months
- Active disease as manifested by at least 3 joints that are swollen and 6 joints that are tender at time of enrollment, and either an erythrocyte sedimentation rate >_28, or a CRP >1.4, or morning stiffness of at least 45 min
- Stable dose of DMARDs for 2 mos before baseline visit, with total duration of DMARD for 6 mos.
- All standard therapy for RA, including DMARDs and combinations of DMARDs will be allowed as long as doses have been stable for 2 mos
- Stable NSAID for 1 month before baseline if on an NSAID
Key exclusion criteria (10 listed)
- A diagnosis of inflammatory arthritis other than rheumatoid arthritis
- Chronic anticoagulation
- Hypersensitivity to fish or fish products or plant products
- A dose of prednisone of > 10 mg/day, or either a change in the prednisone dose or intra-articular corticosteroid injection within one month of the baseline evaluation
- An inability or unwillingness to use an effective form of contraception (females) during the duration of the study
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 |
|---|---|---|
| fish oilAlso: EPAThe object of this intervention is to determine whether treatment of rheumatoid arthritis with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. Each arm of the study will take 13 capsules daily (divided doses) for 18 months. | Drug | 1 |
| borage seed oilAlso: GLABorage oil 13 capsules divided doses daily for 18 months | Drug | 2 |
| combination fish oil and borage seed oilAlso: EPA and GLAFish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months | Drug | 3 |
Primary outcome
The modified Disease Activity Score (DAS28) will be the primary outcome measure.
Time frame: Assessed every 3 months
1 secondary outcome
Reduction of other medication for RA
Time frame: Assessed every 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Robert B Zurier, MD principal investigator
University of Massachusetts, Worcester
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fish oil, borage seed oil and combination fish oil and borage seed oil in people with Rheumatoid Arthritis, run by National Center for Complementary and Integrative Health (NCCIH) at 13 sites in United States.
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 9 inclusion and 10 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 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The modified Disease Activity Score (DAS28) will be the primary outcome measure. (time frame: Assessed every 3 months). 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 25 Aug 2008.