NCT00638950

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2004

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
Last Updated

September 22, 2011

Status Verified

February 1, 2008

Enrollment Period

8 months

First QC Date

February 29, 2008

Last Update Submit

September 21, 2011

Conditions

Rheumatoid Arthritis

Keywords

n-3 LC-PUFARheumatoid arthritisdisease activityinflammationoxidative stressimmune system

Outcome Measures

Primary Outcomes (2)

  • disease activity score DAS28

    12 weeks

  • inflammatory markers (c-reactive protein, erythrocyte sedimentation rate)

    12 weeks

Secondary Outcomes (4)

  • cellular and humoral immunological parameters (CDs)

    12 weeks

  • COX expression

    12 weeks

  • biomarkers of oxidative stress (8-iso-prostaglandin F2α, 15-keto-dh prostaglandin F2α, 8-oxo-deoxy-guanosine)

    12 weeks

  • hydroxypyridinium crosslinks

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

n-3 LC-PUFA

ACTIVE COMPARATOR
Dietary Supplement: n-3 LC-PUFA

Interventions

n-3 LC-PUFADIETARY_SUPPLEMENT

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.

n-3 LC-PUFA
PlaceboDIETARY_SUPPLEMENT

The placebo products were commercial dairy products with comparable fat contents.

Placebo

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19245735BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidInflammation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    University of Jena, Dept. of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 19, 2008

Study Start

September 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

September 22, 2011

Record last verified: 2008-02

Locations

DE(1)