Clinical trial NCT00399282: Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis
Official title: Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Health related quality of life
Omega 3 fatty acids
Vitamin E
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.

Detailed description: The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.

Most of studies on omega-3 fatty acids (omega-3) supplementation in patients with rheumatoid arthritis (RA) have clearly shown potentially beneficial changes in cytokine and eicosanoid metabolism. The overall clinical improvement, however, has been only moderate. One explanation is that an increased intake of omega-3 leads to a reduction in the availability of antioxidants and an increased generation of lipid peroxides. The majority of the anti-inflammatory drugs routinely used nowadays are COX (cyclo-oxygenase) inhibitors. Mechanism of COX II inhibitors is similar of omega-3. So, it is difficult to differentiate omega-3 net effects in some situations. Existing clinical trials on omega-3 and vitamin E (Vit E) are sometimes questioned due to using omega-6 fatty acids as placebo and neglecting omega-6 fatty acid intake in the diet. A comprehensive randomized controlled double-blind trial would have omega-6 fatty acids served as placebo in patients who are well matched in terms of therapies and drugs.

Comparison(s): Comparison of groups supplemented with omega-3, omega-3 with Vit E, and placebo (Medium chain triglycerides: MCT).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis according American college of rheumatology (ACR)

Exclusion Criteria:

* Infection
* Major joint malformations
* Simultaneous diseases like metabolic and gastrointestinal
* Being class IV according to ACR
* Drug dose fluctuations
* History of Vit E and/or omega-3 supplements during past six months
* Gastric irrigations

Primary outcomes:
measure: Score on Persian version of health assessment questionnaire (PE-HAQ) at 0, 6 and 12 weeks
measure: Disease activity score at 0, 6 and 12 weeks
measure: Duration of morning stiffness (in minutes) at 0, 6 and 12 weeks
measure: Joint pain intensity, on a five-point scale (0, absent) at 0, 6 and 12 weeks
measure: Onset of fatigue (in minutes) after walking at 0, 6 and 12 weeks
measure: Ritchie's articular index for pain joints at 0, 6 and 12 weeks
measure: Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at 0, 6 and 12 weeks
measure: Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at 0, 6 and 12 weeks
measure: Classification of functional status in RA according to revised criteria of the American
measure: College of Rheumatology at 0, 6 and 12 weeks
measure: Patient's satisfaction in activities of daily living based on a Persian version of Health Assessment Questionnaire (PE-HAQ) at 0, 6 and 12 weeks
Secondary outcomes:
measure: TNF-alpha at 0, 6 and 12 weeks
measure: IL-1 beta at 0, 6 and 12 weeks
measure: C-reactive protein at 0, 6 and 12 weeks
measure: Erythrocyte sedimentation rate at 0, 6 and 12 weeks
measure: Malondialdehyde at 0, 6 and 12 weeks
measure: Systolic blood pressure at 0, 6 and 12 weeks
measure: Diastolic blood pressure at 0, 6 and 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rheumatology Research Center (RRC), Tehran University for medical Sciences (TUMS)
Study officials:
affiliation: National Nutrition and Food Sciences Technology Institute
name: Reza Rastmanesh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: