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A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
n-3 LC-PUFA
Placebo
Sponsored by
University of Jena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring n-3 LC-PUFA, Rheumatoid arthritis, disease activity, inflammation, oxidative stress, immune system

Eligibility Criteria

35 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clear diagnosis of Rheumatoid Arthritis
  • Patients receiving nonsteroidal anti-inflammatory drugs (NSAID) or corticosteroids (max. 15 mg/d) or both were eligible if dosage had been stable for at least 4 weeks before day 1 of the study and remained below this limit throughout the study
  • Patients on disease-modifying antirheumatic drugs (DMARD) had to be on a constant dosage for at least 8 weeks before and throughout the study

Exclusion Criteria:

  • Subjects with gastrointestinal or metabolic diseases, alcohol abuse, taking dietary supplements (e. g. fish oil capsules), known allergies or foodstuff indigestibility
  • patient's request, serious infections, inadequate control of arthritis symptoms (over 50% increase of the number of swollen or tender joints), reinstitution of therapy with DMARD, or if patient compliance with the study protocol was doubtful.

Sites / Locations

  • University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

n-3 LC-PUFA

Arm Description

Outcomes

Primary Outcome Measures

disease activity score DAS28
inflammatory markers (c-reactive protein, erythrocyte sedimentation rate)

Secondary Outcome Measures

cellular and humoral immunological parameters (CDs)
COX expression
biomarkers of oxidative stress (8-iso-prostaglandin F2α, 15-keto-dh prostaglandin F2α, 8-oxo-deoxy-guanosine)
hydroxypyridinium crosslinks

Full Information

First Posted
February 29, 2008
Last Updated
September 21, 2011
Sponsor
University of Jena
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1. Study Identification

Unique Protocol Identification Number
NCT00638950
Brief Title
A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis
Official Title
Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products: Effects on Pathophysiological Biomarkers in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Jena

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The effects of n-3 LC-PUFA-supplemented dairy products on inflammation and immunological parameters, biomarkers of oxidative stress, serum lipids, and disease activity were determined in patients with rheumatoid arthritis (RA).
Detailed Description
Recent studies suggest that n-3 LC-PUFA may improve cardiovascular and inflammatory diseases. As a precondition for participating in this study, the subjects were provided information in writing and verbally about the details of the study. Informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination in the Clinic for Rheumatology (Internal Medicine III, Friedrich Schiller University, Jena). The RA was diagnosed according to the 1987 revised criteria of the American Rheumatism Association (ARA). Severity of disease activity was evaluated by using the disease activity score DAS 28. Forty five subjects (43 f, 2 m) were randomly divided into two groups to carry out a double-blind, placebo-controlled cross-over study. The study consisted of two investigation periods of 12 weeks, with an eight-week washout period in between. Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially exchanged by special oils with high amounts of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linoleic acid (ALA). The daily dose of n-3 FA amounted to 2.4 g, consisting of 1.1 g ALA, 0.7 g EPA, 0.1 g DPA, and 0.4 g DHA. The placebo products were commercial dairy products with comparable fat contents. Venous blood and 24h urine were collected at the beginning and at the end of each period. The DAS 28 score was assessed at the beginning and the end of each period, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
n-3 LC-PUFA, Rheumatoid arthritis, disease activity, inflammation, oxidative stress, immune system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
n-3 LC-PUFA
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 LC-PUFA
Intervention Description
Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially exchanged by special oils. The daily dose of n-3 FA amounted to 2.4 g, consisting of 1.1 g ALA, 0.7 g EPA, 0.1 g DPA, and 0.4 g DHA.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo products were commercial dairy products with comparable fat contents.
Primary Outcome Measure Information:
Title
disease activity score DAS28
Time Frame
12 weeks
Title
inflammatory markers (c-reactive protein, erythrocyte sedimentation rate)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
cellular and humoral immunological parameters (CDs)
Time Frame
12 weeks
Title
COX expression
Time Frame
12 weeks
Title
biomarkers of oxidative stress (8-iso-prostaglandin F2α, 15-keto-dh prostaglandin F2α, 8-oxo-deoxy-guanosine)
Time Frame
12 weeks
Title
hydroxypyridinium crosslinks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clear diagnosis of Rheumatoid Arthritis Patients receiving nonsteroidal anti-inflammatory drugs (NSAID) or corticosteroids (max. 15 mg/d) or both were eligible if dosage had been stable for at least 4 weeks before day 1 of the study and remained below this limit throughout the study Patients on disease-modifying antirheumatic drugs (DMARD) had to be on a constant dosage for at least 8 weeks before and throughout the study Exclusion Criteria: Subjects with gastrointestinal or metabolic diseases, alcohol abuse, taking dietary supplements (e. g. fish oil capsules), known allergies or foodstuff indigestibility patient's request, serious infections, inadequate control of arthritis symptoms (over 50% increase of the number of swollen or tender joints), reinstitution of therapy with DMARD, or if patient compliance with the study protocol was doubtful.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Jahreis, Prof. Dr.
Organizational Affiliation
University of Jena, Dept. of Nutritional Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19245735
Citation
Dawczynski C, Schubert R, Hein G, Muller A, Eidner T, Vogelsang H, Basu S, Jahreis G. Long-term moderate intervention with n-3 long-chain PUFA-supplemented dairy products: effects on pathophysiological biomarkers in patients with rheumatoid arthritis. Br J Nutr. 2009 May;101(10):1517-26. doi: 10.1017/S0007114508076216. Epub 2009 Feb 27.
Results Reference
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A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis

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