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

S

Shahid Beheshti University of Medical Sciences

Status and phase

Completed
Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: Omega-3 and Vitamin E supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT00399282
NNFTRI-2484

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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