Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399282
• Other study ID #: NNFTRI-2484
• Status: Completed
• Phase: Phase 1
• First received: November 13, 2006
• Last updated: April 17, 2007
• Start date: October 2006
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Omega-3 and Vitamin E supplementation

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rheumatology Research Center (RRC), Tehran University for medical Sciences (TUMS)	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on Persian version of health assessment questionnaire (PE-HAQ) at 0, 6 and 12 weeks
Primary	Disease activity score at 0, 6 and 12 weeks
Primary	Duration of morning stiffness (in minutes) at 0, 6 and 12 weeks
Primary	Joint pain intensity, on a five-point scale (0, absent) at 0, 6 and 12 weeks
Primary	Onset of fatigue (in minutes) after walking at 0, 6 and 12 weeks
Primary	Ritchie’s articular index for pain joints at 0, 6 and 12 weeks
Primary	Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at 0, 6 and 12 weeks
Primary	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
Primary	Classification of functional status in RA according to revised criteria of the American
Primary	College of Rheumatology at 0, 6 and 12 weeks
Primary	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	TNF-alpha at 0, 6 and 12 weeks
Secondary	IL-1 beta at 0, 6 and 12 weeks
Secondary	C-reactive protein at 0, 6 and 12 weeks
Secondary	Erythrocyte sedimentation rate at 0, 6 and 12 weeks
Secondary	Malondialdehyde at 0, 6 and 12 weeks
Secondary	Systolic blood pressure at 0, 6 and 12 weeks
Secondary	Diastolic blood pressure at 0, 6 and 12 weeks