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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Omega-3 and Vitamin E supplementation

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Health related quality of life, Omega 3 fatty acids, Vitamin E

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Outcomes

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

Full Information

NCT ID

NCT00399282

First Posted

November 13, 2006

Last Updated

April 17, 2007

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00399282

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

Double

Allocation

Randomized

Enrollment

75 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Omega-3 and Vitamin E supplementation

Primary Outcome Measure Information:

Title

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

Title

Disease activity score at 0, 6 and 12 weeks

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

College of Rheumatology at 0, 6 and 12 weeks

Title

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 Measure Information:

Title

TNF-alpha at 0, 6 and 12 weeks

Title

IL-1 beta at 0, 6 and 12 weeks

Title

C-reactive protein at 0, 6 and 12 weeks

Title

Erythrocyte sedimentation rate at 0, 6 and 12 weeks

Title

Malondialdehyde at 0, 6 and 12 weeks

Title

Systolic blood pressure at 0, 6 and 12 weeks

Title

Diastolic blood pressure at 0, 6 and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reza Rastmanesh, Ph.D.

Organizational Affiliation

National Nutrition and Food Sciences Technology Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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

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