Suspended

Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

fish oil

+ borage seed oil
+ combination fish oil and borage seed oil
Drug
Who is being recruted

Rheumatoid Arthritis

From 18 to 85 Years
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2006

Summary

Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: August 25, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2006Actual date on which the first participant was enrolled.

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. See Brief Summary

Official TitleTreatment of Rheumatoid Arthritis With Marine and Botanical Oils 
Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: August 25, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
156 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 85 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Rheumatoid Arthritis
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Fish Oil
Group II
Active Comparator
Borage Oil
Group III
Active Comparator
Fish Oil and Borage Oil
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 13 locations
Suspended
UAB Arthritis Clinical Intervention ProgramBirmingham, United StatesSee the location
Suspended
New England Res. AssociatesTrumbull, United States
Suspended
RASF Clinical Research CenterBoca Raton, United States
Suspended
Lake RheumatologyTavares, United States

Suspended13 Study Centers