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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00399282
First received: November 13, 2006
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Omega-3 and Vitamin E supplementation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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
  • Systolic blood pressure at 0, 6 and 12 weeks
  • Diastolic blood pressure at 0, 6 and 12 weeks

Estimated Enrollment: 75
Study Start Date: October 2006
Study Completion Date: April 2007
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

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399282

Locations
Iran, Islamic Republic of
Rheumatology Research Center (RRC), Tehran University for medical Sciences (TUMS)
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti Medical University
Investigators
Principal Investigator: Reza Rastmanesh, Ph.D. National Nutrition and Food Sciences Technology Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399282     History of Changes
Other Study ID Numbers: NNFTRI-2484
Study First Received: November 13, 2006
Last Updated: April 17, 2007
Health Authority: Iran: Ministry of Health

Keywords provided by Shahid Beheshti Medical University:
Rheumatoid arthritis
Health related quality of life
Omega 3 fatty acids
Vitamin E

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 21, 2014