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Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
fish oil
borage seed oil
combination fish oil and borage seed oil
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Fish oil, Borage oil

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Definite RA with onset at > 16 years, with total disease duration of at least 6 months Active disease as manifested by at least 3 joints that are swollen and 6 joints that are tender at time of enrollment, and either an erythrocyte sedimentation rate >_28, or a CRP >1.4, or morning stiffness of at least 45 min Stable dose of DMARDs for 2 mos before baseline visit, with total duration of DMARD for 6 mos. All standard therapy for RA, including DMARDs and combinations of DMARDs will be allowed as long as doses have been stable for 2 mos Stable NSAID for 1 month before baseline if on an NSAID Stable prednisone dose of < 10 mg/day for 1 month before baseline visit, if on prednisone Ability to give and understand all elements of informed consent Absence of comorbid condition which, in the opinion of the physician-investigator, would render the patient unsuitable for the study Willingness to adhere to the clinical protocol. Exclusion Criteria A diagnosis of inflammatory arthritis other than rheumatoid arthritis Chronic anticoagulation Hypersensitivity to fish or fish products or plant products A dose of prednisone of > 10 mg/day, or either a change in the prednisone dose or intra-articular corticosteroid injection within one month of the baseline evaluation An inability or unwillingness to use an effective form of contraception (females) during the duration of the study Pregnant and breast-feeding females Inability or unwillingness to adhere to the study diet Platelet count < 100,000/mm 3 Hemoglobin < 9 g/dl Albumin < 3.3 g

Sites / Locations

  • UAB Arthritis Clinical Intervention Program
  • New England Res. Associates
  • RASF Clinical Research Center
  • Lake Rheumatology
  • Fallon Clinic Health Care
  • Division of Rheumatology, Umass Memorial Health Care
  • Rheumatology and Internal Medicine Associates of West County, PC
  • Joel M. Kremer
  • Prem Tambar, MD
  • Bryn Mawr Medical Specialists
  • Geisinger Medical Center
  • Altoona Center for Clinical Research
  • Piedmont Arthritis Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Fish Oil

Borage Oil

Fish Oil and Borage Oil

Outcomes

Primary Outcome Measures

The modified Disease Activity Score (DAS28) will be the primary outcome measure.

Secondary Outcome Measures

Reduction of other medication for RA

Full Information

First Posted
November 13, 2003
Last Updated
August 22, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00072982
Brief Title
Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
Official Title
Treatment of Rheumatoid Arthritis With Marine and Botanical Oils
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. This study will also investigate the biochemical, immunological, and molecular mechanism responsible for the therapeutic effects of these fatty acids. Each patient will be followed for eighteen months.
Detailed Description
See Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Fish oil, Borage oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Fish Oil
Arm Title
2
Arm Type
Active Comparator
Arm Description
Borage Oil
Arm Title
3
Arm Type
Active Comparator
Arm Description
Fish Oil and Borage Oil
Intervention Type
Drug
Intervention Name(s)
fish oil
Other Intervention Name(s)
EPA
Intervention Description
The object of this intervention is to determine whether treatment of rheumatoid arthritis with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. Each arm of the study will take 13 capsules daily (divided doses) for 18 months.
Intervention Type
Drug
Intervention Name(s)
borage seed oil
Other Intervention Name(s)
GLA
Intervention Description
Borage oil 13 capsules divided doses daily for 18 months
Intervention Type
Drug
Intervention Name(s)
combination fish oil and borage seed oil
Other Intervention Name(s)
EPA and GLA
Intervention Description
Fish oil and borage seed oil capsules - 13 capsules to be be taken daily (divided doses) for a period of 18 months
Primary Outcome Measure Information:
Title
The modified Disease Activity Score (DAS28) will be the primary outcome measure.
Time Frame
Assessed every 3 months
Secondary Outcome Measure Information:
Title
Reduction of other medication for RA
Time Frame
Assessed every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Definite RA with onset at > 16 years, with total disease duration of at least 6 months Active disease as manifested by at least 3 joints that are swollen and 6 joints that are tender at time of enrollment, and either an erythrocyte sedimentation rate >_28, or a CRP >1.4, or morning stiffness of at least 45 min Stable dose of DMARDs for 2 mos before baseline visit, with total duration of DMARD for 6 mos. All standard therapy for RA, including DMARDs and combinations of DMARDs will be allowed as long as doses have been stable for 2 mos Stable NSAID for 1 month before baseline if on an NSAID Stable prednisone dose of < 10 mg/day for 1 month before baseline visit, if on prednisone Ability to give and understand all elements of informed consent Absence of comorbid condition which, in the opinion of the physician-investigator, would render the patient unsuitable for the study Willingness to adhere to the clinical protocol. Exclusion Criteria A diagnosis of inflammatory arthritis other than rheumatoid arthritis Chronic anticoagulation Hypersensitivity to fish or fish products or plant products A dose of prednisone of > 10 mg/day, or either a change in the prednisone dose or intra-articular corticosteroid injection within one month of the baseline evaluation An inability or unwillingness to use an effective form of contraception (females) during the duration of the study Pregnant and breast-feeding females Inability or unwillingness to adhere to the study diet Platelet count < 100,000/mm 3 Hemoglobin < 9 g/dl Albumin < 3.3 g
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Zurier, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Arthritis Clinical Intervention Program
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35297
Country
United States
Facility Name
New England Res. Associates
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
RASF Clinical Research Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Lake Rheumatology
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Fallon Clinic Health Care
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Division of Rheumatology, Umass Memorial Health Care
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Rheumatology and Internal Medicine Associates of West County, PC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Joel M. Kremer
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Prem Tambar, MD
City
Niagara Falls
State/Province
New York
ZIP/Postal Code
14303
Country
United States
Facility Name
Bryn Mawr Medical Specialists
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Piedmont Arthritis Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States

12. IPD Sharing Statement

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Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

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