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Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01742468
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : October 7, 2015
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena

Tracking Information
First Submitted Date  ICMJE December 3, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date October 7, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2015)
Sum of tender and swollen joints (68/66), disease activity score DAS 28, ultrasound score US-7 [ Time Frame: 10 weeks ]
Disease activity parameters
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
arachidonic acid/docosahexaenoic acid ratio in plasmal lipids and erythrocyte membranes [ Time Frame: 10 weeks ]
arachidonic acid is a precursor of eicosanoids (leukotriens 4 series, prostaglandins 2 series) docosahexaenoic acid is a precursor of (resolvins and protectins (pro-resolving)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2015)
  • Inflammation markers such as erythrocyte sedimation rate (ESR), C reactive protein (CRP), adhesion molecules, cytokines, rheumascan [ Time Frame: 10 weeks ]
    Further disease acitvity parameters
  • Concentrations of arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid in plasma lipids and erythrocyte lipids [ Time Frame: 10 weeks ]
    Precursors of eicosanoids (leukotriens, prostaglandins, thromboxanes) and docosanoids (resolvines)
  • Lipid mediators formed by lipoxygenases, cyclogenases [ Time Frame: 10 weeks ]
    Lipidmediators derived from arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
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 ]
disease acitvity parameters
Current Other Pre-specified Outcome Measures
 (submitted: December 4, 2012)
Blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triacylglycerol (TAG), ox LDL, lipoprotein a) [ Time Frame: 10 weeks ]
Cardiovascular risk factors
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis
Official Title  ICMJE 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
Brief Summary 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.
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 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Dietary Supplement: long-chain n-3 PUFA
    Dietary supplement: n-3 LC-PUFA = Microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany (rich in docosahexaenoic acid (DHA)); Dosage: 8 g oil per day = 2.11 g DHA per day; Dosage form: included in 60 g sausage, 8 g tomato spread, 30 g milk powder
    Other Name: n-3 LC-PUFA
  • Dietary Supplement: sunflower oil
    Dietary supplement: sunflower oil Name: sunflower oil (PPM, Magdeburg, Germany); Dosage: 8 g per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Dietary supplement: n-3 LC-PUFA
    Name: microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany; rich in docosahexaenoic acid (DHA); Dosage: 8 g oil per day = 2.11 g DHA per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder
    Intervention: Dietary Supplement: long-chain n-3 PUFA
  • Placebo Comparator: Dietary supplement: sunflower oil
    Name: sunflower oil (PPM, Magdeburg, Germany); Dosage: 8 g per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder
    Intervention: Dietary Supplement: sunflower oil
Publications * Dawczynski C, Dittrich M, Neumann T, Goetze K, Welzel A, Oelzner P, Völker S, Schaible AM, Troisi F, Thomas L, Pace S, Koeberle A, Werz O, Schlattmann P, Lorkowski S, Jahreis G. Docosahexaenoic acid in the treatment of rheumatoid arthritis: A double-blind, placebo-controlled, randomized cross-over study with microalgae vs. sunflower oil. Clin Nutr. 2018 Apr;37(2):494-504. doi: 10.1016/j.clnu.2017.02.021. Epub 2017 Mar 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2015)
38
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
35
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has a diagnosis of RA (according to the ACR classification criteria, revised 2010) for at least 6 months prior to randomization.
  • Patient has a moderate disease activity as defined by disease activity score DAS28 ≥ 2.4
  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01742468
Other Study ID Numbers  ICMJE H53-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Jahreis, University of Jena
Study Sponsor  ICMJE University of Jena
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Gerhard Jahreis, Professor Friedrich Schiller University Jena, Department of Nutritional Physiology
PRS Account University of Jena
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP