Rheumatoid ArthritisPhase 2NCT01179971
n-3 and n-6 Fatty Acids in Rheumatoid Arthritis
A Phase 2 study testing Fish oil, gamma-linolenic acid in people with Rheumatoid Arthritis, run by Charite University, Berlin, Germany.
Trial summary
Purpose: To investigate into the differential effects of polyunsaturated fatty acids as compared to standard control therapy (olive oil) on disease activity and biochemical parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Fish oil, gamma-linolenic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid or Psoriasis arthritis
Who cannot join
- Severe diseases of heart, liver, lung airways
- Non-compliance
About this study
Official title: Incorporation of n-3 Long Chain Polyunsaturated Fatty Acids and Gamma Linolenic Acid in Plasma Lipids, Cholesteryl Esters, and Erythrocyte Membranes and Their Influence on Disease Activity in Patients With Rheumatoid Arthritis
Purpose: To investigate into the differential effects of polyunsaturated fatty acids as compared to standard control therapy (olive oil) on disease activity and biochemical parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).
Read the detailed description
Methods: Double-blinded, four-armed randomised controlled trial with 3.0 g/d of either n-3 long chain polyunsaturated fatty acids (LC-PUFA) or gamma linolenic acid (GLA), resp. the combination of 1.5 g/d of each, resp. 3.0 g/d of olive oil over 12 weeks. Outcome parameters disease activity score (DAS28), C-reactive protein, concentrations of n-3 LC-PUFA, resp. GLA in plasma lipids (PL), cholesterol esters (CE), and erythrocyte membranes (EM), and serum concentrations of arachidonic acid (AA). Conventional antirheumatic and immunosuppressive therapies could be changed only within defined limits.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Fish oil, gamma-linolenic acid
- Keywords
- n-3 fatty acids, n-6 fatty acids, anti-inflammatory action, clinical trial, randomized double-blinded, incorporation of fatty acids
- 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 oil, gamma-linolenic acidDietary supplement
Also called Fish oil, omega-6 fatty acids
3 g/d DHA + EPA
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | 3g/d Receives: Dietary Supplement: Fish oil, gamma-linolenic acid |
| Gamma-linolenic Acid | Experimental | 3g/d gamma-linolenic acid Receives: Dietary Supplement: Fish oil, gamma-linolenic acid |
| Fish oil plus GLA | Experimental | 1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid Receives: Dietary Supplement: Fish oil, gamma-linolenic acid |
| Olive oil | Sham comparator | 3 g/d olive oil Receives: Dietary Supplement: Fish oil, gamma-linolenic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
incorporation of eicosapentaenoic acid in plasma lipids
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids
Measured: 12 weeks
Secondary outcomes (4)
Disease activity score 28 (DAS28, EULAR)
Disease activity as determinated by counts of swollen and tender joints, patient's judgement and erythrocyte sedimentation rate
Measured: 12 weeks
C-reactive protein
most common marker of acute systemic inflammation
Measured: 12 weeks
International Normalized Ratio (INR)
most common single marker for crude quantification of hemostasis
Measured: 12 weeks
Tolerability
registration of complaints for taste, odor, or mechanical properties of the supplements
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena
- Investigators
- Rainer Stange, MD, PhD, Principal investigator, Immanuel Krankenhaus and Charite Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179971
- Sponsor's protocol ID
- Charite-n-3-n-6
- Status last verified
- Aug 2010
- First submitted
- 4 Aug 2010
- Last updated
- 26 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Dawczynski C, Hackermeier U, Viehweger M, Stange R, Springer M, Jahreis G. Incorporation of n-3 PUFA and gamma-linolenic acid in blood lipids and red blood cell lipids together with their influence on disease activity in patients with chronic inflammatory arthritis--a randomized controlled human intervention trial. Lipids Health Dis. 2011 Aug 4;10:130. doi: 10.1186/1476-511X-10-130.
PubMed 21816071
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation of n-3 Long Chain Polyunsaturated Fatty Acids and Gamma Linolenic Acid in Plasma Lipids, Cholesteryl Esters, and Erythrocyte Membranes and Their Influence on Disease Activity in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01179971
- Acronym / sponsor ID
- Charite-n-3-n-6
- Conditions
- Rheumatoid Arthritis
- Keywords
- n-3 fatty acids, n-6 fatty acids, anti-inflammatory action, clinical trial, randomized double-blinded, incorporation of fatty acids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of Jena
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Aug 2010 (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.
Purpose: To investigate into the differential effects of polyunsaturated fatty acids as compared to standard control therapy (olive oil) on disease activity and biochemical parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).
Detailed description
Methods: Double-blinded, four-armed randomised controlled trial with 3.0 g/d of either n-3 long chain polyunsaturated fatty acids (LC-PUFA) or gamma linolenic acid (GLA), resp. the combination of 1.5 g/d of each, resp. 3.0 g/d of olive oil over 12 weeks. Outcome parameters disease activity score (DAS28), C-reactive protein, concentrations of n-3 LC-PUFA, resp. GLA in plasma lipids (PL), cholesterol esters (CE), and erythrocyte membranes (EM), and serum concentrations of arachidonic acid (AA). Conventional antirheumatic and immunosuppressive therapies could be changed only within defined limits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Experimental | Dietary Supplement: Fish oil, gamma-linolenic acid3g/d |
| Gamma-linolenic Acid | Experimental | Dietary Supplement: Fish oil, gamma-linolenic acid3g/d gamma-linolenic acid |
| Fish oil plus GLA | Experimental | Dietary Supplement: Fish oil, gamma-linolenic acid1.5 g/d DHA + EPA plus 1.5g/d gamma-linolenic acid |
| Olive oil | Sham comparator | Dietary Supplement: Fish oil, gamma-linolenic acid3 g/d olive oil |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatoid or Psoriasis arthritis
Key exclusion criteria (2 listed)
- Severe diseases of heart, liver, lung airways
- Non-compliance
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 oil, gamma-linolenic acidAlso: Fish oil, omega-6 fatty acids3 g/d DHA + EPA | Dietary supplement | Fish oil, Fish oil plus GLA, Gamma-linolenic Acid, Olive oil |
Primary outcome
incorporation of eicosapentaenoic acid in plasma lipids
Time frame: 12 weeks
ratio of arachidonic acid/eicosapentaenoic acid in plasma lipids
4 secondary outcomes
Disease activity score 28 (DAS28, EULAR)
Time frame: 12 weeks
C-reactive protein
Time frame: 12 weeks
International Normalized Ratio (INR)
Time frame: 12 weeks
Tolerability
Time frame: 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 26 Aug 2010.
- Derived from this study: PubMed 21816071Dawczynski C, Hackermeier U, Viehweger M, Stange R, Springer M, Jahreis G. Incorporation of n-3 PUFA and gamma-linolenic acid in blood lipids and red blood cell lipids together with their influence on disease activity in patients with chronic inflammatory arthritis--a randomized controlled human intervention trial. Lipids Health Dis. 2011 Aug 4;10:130. doi: 10.1186/1476-511X-10-130.
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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.
Rainer Stange, MD, PhD principal investigator
Immanuel Krankenhaus and Charite Berlin
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fish oil, gamma-linolenic acid in people with Rheumatoid Arthritis, run by Charite University, Berlin, Germany.
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 2 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 26 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
incorporation of eicosapentaenoic acid in plasma lipids (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179971, which also lists 1 linked publication.
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 26 Aug 2010.