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

NCT00399282 | Completed Phase 1 DMC

• 1 other identifier: NNFTRI-2484
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Health related quality of life; Omega 3 fatty acids; Vitamin E

Outcome Measures

Primary Outcomes (11)

• Score on Persian version of health assessment questionnaire (PE-HAQ) at 0, 6 and 12 weeks

• Disease activity score at 0, 6 and 12 weeks

• Duration of morning stiffness (in minutes) at 0, 6 and 12 weeks

• Joint pain intensity, on a five-point scale (0, absent) at 0, 6 and 12 weeks

• Onset of fatigue (in minutes) after walking at 0, 6 and 12 weeks

• Ritchie's articular index for pain joints at 0, 6 and 12 weeks

• Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at 0, 6 and 12 weeks

• 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

• Classification of functional status in RA according to revised criteria of the American

• College of Rheumatology at 0, 6 and 12 weeks

• 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 (7)

• TNF-alpha at 0, 6 and 12 weeks

• IL-1 beta at 0, 6 and 12 weeks

• C-reactive protein at 0, 6 and 12 weeks

• Erythrocyte sedimentation rate at 0, 6 and 12 weeks

• Malondialdehyde at 0, 6 and 12 weeks

Interventions

Omega-3 and Vitamin E supplementation DRUG

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Rheumatology Research Center (RRC), Tehran University for medical Sciences (TUMS)

Tehran, Iran

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Reza Rastmanesh, Ph.D.

  National Nutrition and Food Sciences Technology Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 14, 2006
• Study Start: October 1, 2006
• Study Completion: April 1, 2007
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

IR (1)