Intervention With n-3 Polyunsaturated Fatty Acids in Patients With Rheumatoid Arthritis
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Purpose
The study was performed to investigate the effects of a daily consumption of n-3 LC-PUFA supplemented products (sausage, tomato spread, milk beverage) on disease activity, inflammatory markers, and cardiovascular risk factors in patients with rheumatoid arthritis.
| Condition | Intervention |
|---|---|
|
Inflamatory Markers and Disease Activity |
Dietary Supplement: n-3 LC-PUFA Dietary Supplement: placebo (sunflower oil) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intervention With Products Enriched With Long Chain n-3 Polyunsaturated Fatty Acids (n-3 LC-PUFA)in Patients With Rheumatoid Arthritis - Influence on Disease Activity and Inflammation Status |
- arachidonic acid/docosahexaenoic acid ratio in plasmal lipids and erythrocyte membranes [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]arachidonic acid is a precursor of eicosanoids (leukotriens 4 series, prostaglandins 2 series) docosahexaenoic acid is a precursor of (resolvins and protectins (pro-resolving)
- inflammation markers such as erythrocyte sedimation rate (ESR), C reactive protein (CRP), adhesion molecules, disease activity score DAS 28 and DAS68, US-7 score, rheumascan [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]disease acitvity parameters
- blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triacylglycerol (TAG), ox LDL, lipoprotein a) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]cardiovascular risk factors
| Estimated Enrollment: | 35 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | May 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: n-3 LC-PUFA
algal oil (rich in docosahexaenoic acid) 8 g/day (included in 60g sausage, 8g tomato spread, 30g milk powder)
|
Dietary Supplement: n-3 LC-PUFA
verum (algal oil)
|
|
Placebo Comparator: sunflower oil
sunflower oil 8 g/day (included in 60g sausage, 8g tomato spread, 30g milk powder)
|
Dietary Supplement: placebo (sunflower oil) |
Detailed Description:
Recent studies suggest that the daily intake of n-3 LC-PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) can support the therapy of chronic-inflammatory diseases and might be useful to prevent coronary heart diseases. The majority of these studies do not differentiate between the effects of EPA and DHA. The present study investigate the effects of DHA in patients with rheumatoid arthritis.
As a precondition for participating in this study, the patients were provided information in writing and verbally about the details of the study. Written informed consent was obtained from all volunteers. Before the beginning of the study, all patients were subject to a medical examination by their general rheumatologist. Thirty five patients with rheumatoid arthritis (DAS ≥ 2.6, erythrocyte sedimation rate (ESR (1h) ≥ 12 mm) should entered the study.
The placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 weeks, with a ten-week washout period in between. After the washout period the intervention was crossed between the groups and the respective products were consumed for another 10 weeks. Patients in the placebo period receive 60g sausage, 8g tomato spread and one bottle of the milk beverage daily. These products were enriched with sunflower oil (8g/d).
In the intervention period, the products (60g sausage, 8g tomato spread and one bottle of the milk beverage) were enriched with 8g alga oil (IOI) The daily dose of docosahexaenoic acid (DHA) amounted to 2.8 g.
Venous blood is collected at the beginning and at the end of each period.
• Disease activity was determined by joint score DAS68, rheumascan, common inflammatory markers (ESR, C reactive protein), ultrasonic (US-7 score), HAQ questionnaire and further lifestyle forms
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria for at least 6 months prior to randomization.
- Patient has a moderate disease activity as defined by disease activity score DAS28 ≥ 2.6, ESR ≥ 12 mm/hour.
- Patient has the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.
- stable dosis of disease-modifying antirheumatic drugs within 4 weeks prior to randomization and presumably over the study periods (30 weeks).
Exclusion Criteria:
- Intra-articular corticosteroids within 4 weeks prior to randomization or blood sample taking
- Patients are permitted to receive either oral or parenteral glucocorticoids equivalent to ≤10 mg daily prednisone and nonsteroidal anti-inflammatory drug, if they have received a stable dose for at least 4 weeks prior to randomization and presumably over the study periods (30 weeks).
Contacts and Locations| Germany | |
| Friedrich Schiller University, Institute of Nutrition | Active, not recruiting |
| Jena, Germany, 07743 | |
| Friedrich Schiller University, Clinic for Internal Medicine | Recruiting |
| Jena, Germany, 07743 | |
| Contact: Peter Oelzner, Professor +49/3641 9324326 peter.oelzner@med.uni-jena.de | |
| Contact: Thomas Neumann, PhD +49/3641 9324595 thomas.neumann@med.uni-jena.de | |
| Sub-Investigator: Peter Oelzner, Professor | |
More Information
No publications provided
| Responsible Party: | Gerhard Jahreis, Professor, University of Jena |
| ClinicalTrials.gov Identifier: | NCT01742468 History of Changes |
| Other Study ID Numbers: | H53-12 |
| Study First Received: | December 3, 2012 |
| Last Updated: | December 5, 2012 |
| Health Authority: | Ethics committee of the medical faculty of the Friedrich Schiller University Jena: Germany |
Keywords provided by University of Jena:
|
n-3 LC-PUFA, DHA, rheumatoid arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013