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NCT Number: NCT00399282

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

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.

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Key information

Conditions

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

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Tehran, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 and Vitamin E supplementation

Drug

Primary outcomes

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

  2. Disease activity score at 0, 6 and 12 weeks

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

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

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

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

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

  8. 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

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

  10. College of Rheumatology at 0, 6 and 12 weeks

  11. 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

  1. TNF-alpha at 0, 6 and 12 weeks

  2. IL-1 beta at 0, 6 and 12 weeks

  3. C-reactive protein at 0, 6 and 12 weeks

  4. Erythrocyte sedimentation rate at 0, 6 and 12 weeks

  5. Malondialdehyde at 0, 6 and 12 weeks

  6. Systolic blood pressure at 0, 6 and 12 weeks

  7. Diastolic blood pressure at 0, 6 and 12 weeks

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Nov 14, 2006
Registry last updated
Apr 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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