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

NCT01742468 | Completed DMC

• 1 other identifier: H53-12
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Keywords

n-3 LC-PUFA, DHA, rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Sum of tender and swollen joints (68/66), disease activity score DAS 28, ultrasound score US-7

  Disease activity parameters

  10 weeks

Secondary Outcomes (3)

• Inflammation markers such as erythrocyte sedimation rate (ESR), C reactive protein (CRP), adhesion molecules, cytokines, rheumascan

  10 weeks

• Concentrations of arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid in plasma lipids and erythrocyte lipids

  10 weeks

• Lipid mediators formed by lipoxygenases, cyclogenases

  10 weeks

Other Outcomes (1)

• Blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triacylglycerol (TAG), ox LDL, lipoprotein a)

  10 weeks

Study Arms (2)

Dietary supplement: n-3 LC-PUFA

EXPERIMENTAL

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

Dietary Supplement: long-chain n-3 PUFA

Dietary supplement: sunflower oil

PLACEBO COMPARATOR

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

Dietary Supplement: sunflower oil

Interventions

long-chain n-3 PUFA DIETARY_SUPPLEMENT

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

Also known as: n-3 LC-PUFA

Dietary supplement: n-3 LC-PUFA

sunflower oil DIETARY_SUPPLEMENT

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

Also known as: placebo

Dietary supplement: sunflower oil

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Jena: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (2)

Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

Location

Friedrich Schiller University, Clinic for Internal Medicine

Jena, 07743, Germany

Location

Related Publications (1)

• Dawczynski C, Dittrich M, Neumann T, Goetze K, Welzel A, Oelzner P, Volker 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.

  PMID: 28302406 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Gerhard Jahreis, Professor

  Friedrich Schiller University Jena, Department of Nutritional Physiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 7, 2015

Record last verified: 2013-10

Locations

DE (2)