Rheumatoid Arthritis Clinical Trial
— ADIRAOfficial title:
ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)
NCT number | NCT02941055 |
Other study ID # | ADIRA2016 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2017 |
Est. completion date | May 9, 2018 |
Verified date | March 2019 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the population, and where many patients in spite of modern pharmacological treatment fail to reach remission. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will decrease disease activity and improve quality of life in patients with established RA.
Status | Completed |
Enrollment | 56 |
Est. completion date | May 9, 2018 |
Est. primary completion date | May 9, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Subjects with established RA, disease duration >2 years, disease activity DAS28 >= 2.6 and a disease that is clinically stable and under adequate control and medication, will be invited to participate. Exclusion Criteria: - Other life threatening diseases, pregnancy, lactation, food intolerance or allergy to food included in the trial, ability to understand information in Swedish |
Country | Name | City | State |
---|---|---|---|
Sweden | The University of Gothenburg | Göteborg |
Lead Sponsor | Collaborator |
---|---|
Göteborg University | Sahlgrenska University Hospital, Sweden |
Sweden,
Bärebring L, Winkvist A, Gjertsson I, Lindqvist HM. Poor Dietary Quality Is Associated with Increased Inflammation in Swedish Patients with Rheumatoid Arthritis. Nutrients. 2018 Oct 18;10(10). pii: E1535. doi: 10.3390/nu10101535. — View Citation
Winkvist A, Bärebring L, Gjertsson I, Ellegård L, Lindqvist HM. A randomized controlled cross-over trial investigating the effect of anti-inflammatory diet on disease activity and quality of life in rheumatoid arthritis: the Anti-inflammatory Diet In Rheumatoid Arthritis (ADIRA) study protocol. Nutr J. 2018 Apr 20;17(1):44. doi: 10.1186/s12937-018-0354-x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost effectiveness of study intervention by Health-related quality of life | Health-related quality of life | 10 weeks on each diet | |
Other | Cost effectiveness of study intervention by QALYs | Quality-adjusted life years (QALYs) | 10 weeks on each diet | |
Other | Changes in blood lipids between the two diet interventions, within each person | TAG, LDL, HDL etc | 10 weeks on each diet | |
Other | Effects of genetic polymorphisms in dietary response | Genetic analyses | 10 weeks on each diet | |
Primary | Difference in disease activity score DAS28 (ie a composite score including tender and swollen joints count, ESR or CRP, VAS scale global health) between the two diet interventions, within each person | Measured clinically | 10 weeks of each diet | |
Secondary | Difference in SF-36 between the two diet interventions, within each person | Measured by validated instruments | 10 weeks on each diet | |
Secondary | Difference and changes in metabolites between the two diet interventions, within each person | Metabolomics with NMR and MS analyses of serum and urine samples | 10 weeks on each diet | |
Secondary | Differences in inflammatory markers between the two diet interventions, within each person | hs-CRP, cytokines in blood | 10 weeks on each diet | |
Secondary | Difference in EQ5D between the two diet interventions, within each person | Measured by validated instruments | 10 weeks on each diet | |
Secondary | Difference in HAQ between the two diet interventions, within each person | Measured by validated instruments | 10 weeks on each diet |
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