Condition category
Musculoskeletal Diseases
Date applied
01/12/2007
Date assigned
03/01/2008
Last edited
03/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.meduni-graz.at/englisch/

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

Publication citations

Additional files

Editorial Notes