Rheumatoid Arthritis Clinical Trial
Official title:
Intervention With Products Enriched With Long Chain n-3 Polyunsaturated Fatty Acids (n-3 LC-PUFA) From Microalgae Oil in Patients With Rheumatoid Arthritis - Influence on Disease Activity and Inflammation Status
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.
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
therapeutic potential of DHA in patients with rheumatoid arthritis.
As a precondition for participating in this study, the patients were provided information in
writing and verbally form 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-eight patients with
rheumatoid arthritis (DAS ≥ 2.4) 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 further 10 weeks).
Patients in the placebo period receive 60 g sausage, 8 g tomato spread and 30 g milk powder
(= 200 mL milk beverage) daily. These products were enriched with sunflower oil (8 g/d).
In the intervention period, the products (60 g sausage, 8 g tomato spread and 30 g milk
powder (= 200 mL milk beverage) were enriched with 8 g microalgae oil (Schizochytrium sp.,
Maris DHA oil, no. 3790, IOI, Hamburg, Germany). In this group, the daily dose of
docosahexaenoic acid (DHA) amounted to 2.11 g.
Venous blood is collected at the beginning and at the end of each period.
• Disease activity was determined by sum of tender and swollen joints (68/66), joint score
DAS28, ultrasound score (US-7 score), rheumascan, inflammatory markers (ESR, C reactive
protein), HAQ questionnaire and further lifestyle forms
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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