N3 fatty acids as adjuvant therapy in rheumatoid arthritis (N3-fettsäuren als adjuvante therapie bei rheumatoider arthritis)
| ISRCTN | ISRCTN48092875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48092875 |
| Secondary identifying numbers | 10-184 ex 99/00 |
- Submission date
- 01/12/2007
- Registration date
- 03/01/2008
- Last edited
- 03/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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 Babak Bahadori
Scientific
Scientific
State Hospital Muerzzuschlag
Department of Internal Medicine
Grazerstr. 63-65
Muerzzuschlag
8680
Austria
| b.bahadori@gmx.at |
Study information
| Study design | Randomized, double-blinded, placebo-controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Omega-3 fatty acids infusions may show earlier and superior antiinflammatory effects in patients with rheumatoid arthritis than oral administered ones (as shown in earlier trials), and we presumed the beneficial effects may be maintained by following oral omega-3 fatty acid administration. |
| Ethics approval(s) | This trial was approved by the ethics committee of the Medical University of Graz on 10th July 2000. |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Intervention group: Infusions of omega-3 fatty acids once daily for 14 days (Infusion speed: 0.5 ml/kg body weight and hour), followed by oral administration of omega-3 fatty acids up to 6 months. Control group: Placebo infusions once daily for 14 days (Infusion speed: 0.5 ml/kg body weight and hour), followed by oral administration of placebo up to 6 months. Verum: Infusions: Fish oil emulsion (Omegaven® Fresenius). 100 ml Omegaven® contained 10 g fish oil with 2.03 g EicosaPentaenoic Acid (EPA) and 2.26 g DocosaHexaenoic Acid (DHA) (and 0.02 mg a-tocopherol as antioxidat) Capsules: Fish oil. One capsule contained 1 g fish oil with 0.20 g EPA and 0.23 g DHA (and 0.02 mg a-tocopherol as antioxidant) Placebo: Infusions: NaCl 0.9% (physiological sodium chloride solution) Capsules: Paraffin wax Randomisation was done by a hospital pharmacist who prepared the bottles and other infusion material, so that neither the patients nor the staff could identify them as verum or placebo. Additionally, the study conducting staff was not allowed to enter the inpatient area while the patients received their infusions. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Omega-3 fatty acids |
| Primary outcome measure | The following were assessed at baseline, during infusion phase (after week 1 and after week 2) and during capsule phase (after two weeks [end of month 1] and then monthly until the end of month 6): 1. Swollen joints 2. Tender joints 3. Erythrocyte Sedimentation Rate (ESR) 4. C-Reactive Protein (CRP) |
| Secondary outcome measures | The following were assessed at baseline, during infusion phase (after week 1 and after week 2) and during capsule phase (after two weeks [end of month 1] and then monthly until the end of month 6): 1. Disease Activity Score (DAS) 2. Rheumatoid Arthritis Disease Activity Index (RADAI) 3. Health Assessment Questionnaire (HAQ) 4. 36-item Short Form health survey (SF-36) |
| Overall study start date | 11/07/2000 |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Patients at least 19 years of age and should not be older than 85 years 2. Patients suffering from Rheumatoid Arthritis (RA), according to American College of Rheumatology (ACR) criteria, for at least (>=) 6 months 3. Patients with active RA who meet following criteria: 3.1. >= 6 swollen joints 3.2. >= 6 tender joints 3.3. >= 1 of following criteria: a. Joint morning stiffness >= 45 minutes b. Erythrocyte Sedimentation Rate (ESR) >= 28 mm c. C-Reactive Protein (CRP) >= 20 mg/l (normal range: 0 - 9) 4. No pregnant or breast feeding women allowed; monthly negative pregnancy test in women of reproductive age 5. Participant doesn't have a severe concomitant physical or mental illness 6. Participant has to be able to follow the study procedures 7. No severe malfunctioning of the liver, kidneys, bone marrow, blood clotting system 8. Stable dosages of RA medication for at least 1 month prior to baseline: 8.1. DMARD therapy with methotrexate of at least 10 mg per week over 4 months 8.2. Prednisone <=10 mg daily 9. No injection of glucocorticoids into a joint within 3 month prior to baseline 10. Participant must not have legal conflict 11. Participant must not have alcohol or drug abuse problems 12. Written informed consent signed by the participant |
| Key exclusion criteria | 1. Known allergy against fish oil or any other substance of the study medication 2. Participant is younger than 19 years of age 3. Patient simultaneously participates in another trial 4. Participant doesn't sign the written informed consent. 5. No stable dosage of RA medication 1 month prior to baseline 6. Injection of glucocorticoids into a joint within 3 month prior to baseline 7. Pregnant or breast feeding women; positive pregnancy test in women of reproductive age 8. Patient has legal conflicts 9. Patient has alcohol or drug abuse problems 10. Severe concomitant physical or mental illness 11. Participant is physically or mentally unable to follow the study procedures 12. Hereditary disorder of lipid metabolism 13. Blood triglyceride levels >300 mg/dl 14. Patients with uncontrolled diabetes mellitus 15. Severe malfunctioning of the liver, kidneys, bone marrow, blood clotting system: 15.1. Creatinin clearance <=30 ml/min 15.2. Elevated levels of ALanine aminoTransferase (ALT) 2 fold above the upper normal range 15.3. Leucopenia <=2,500/ml, red blood cells <=2.5 mill/ml, hemoglobin <=9 mg/dl, platelets <=70,000/ml 16. Severe cardiovascular disease 17. Known neoplasms |
| Date of first enrolment | 11/07/2000 |
| Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- Austria
Study participating centre
State Hospital Muerzzuschlag
Muerzzuschlag
8680
Austria
8680
Austria
Sponsor information
Medical University of Graz (Austria)
University/education
University/education
Universitätsplatz 3
Graz
A-8010
Austria
| Website | http://www.meduni-graz.at/englisch/ |
|---|---|
"ROR" |
https://ror.org/02n0bts35 |
Funders
Funder type
Other
Investigator-funded (This trial is a physician initiated study) (Austria)
No information available
Fresenius Kabi Austria (Provided Omega-3 infusions only)
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 |
