Contact information
Type
Scientific
Primary contact
Dr Babak Bahadori
ORCID ID
Contact details
State Hospital Muerzzuschlag
Department of Internal Medicine
Grazerstr. 63-65
Muerzzuschlag
8680
Austria
b.bahadori@gmx.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10-184 ex 99/00
Study information
Scientific title
Acronym
Study hypothesis
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
This trial was approved by the ethics committee of the Medical University of Graz on 10th July 2000.
Study design
Randomized, double-blinded, placebo-controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Omega-3 fatty acids
Primary 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. 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 trial start date
11/07/2000
Overall trial end date
30/04/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
11/07/2000
Recruitment end date
30/04/2004
Locations
Countries of recruitment
Austria
Trial participating centre
State Hospital Muerzzuschlag
Muerzzuschlag
8680
Austria
Sponsor information
Organisation
Medical University of Graz (Austria)
Sponsor details
Universitätsplatz 3
Graz
A-8010
Austria
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator-funded (This trial is a physician initiated study) (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Fresenius Kabi Austria (Provided Omega-3 infusions only)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary