An interventional study of Omega-3 and Placebo (soya) in Spondyloarthritis, Rheumatoid Arthritis and Polyarthritis, sponsored by Haukeland University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment
Background: Patients with inflammatory rheumatic diseases (IRD) are prone to malnutrition for several reasons. The diseases and treatment can cause reduced intake and absorption of nutrients and the inflammatory processes may cause an increased demand for nutrients, especially proteins. Studies report that nutritional status can affect disease activity. Dietary supplement of 3-4 gram omega-3 has shown beneficial effect upon disease activity in patients with IRD.
Aim: To investigate whether improved dietary intake with and without supplements of omega-3 will affect disease activity in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA).
Hypothesis 1: A systematic change of diet in line with the Norwegian dietary guidelines, which will result in increased intake of, among other nutrients, omega-3 fatty acids and complete protein, as well as reduced intake of saturated fat and sugar, will improve nutritional status and reduce disease activity.
Hypothesis 2: A systematic change of diet (as above), included a high dose of omega-3 will further improve nutritional status and reduce disease activity compared with placebo.
Design: A DB-RCT-study will be conducted. All patients will receive individualized dietary guidance by a clinical dietician for 12 weeks, before randomization to supplements of omega-3 or placebo, for 24 weeks. The supplement will be blinded for the participants, researchers and physicians.
Clinical implications: The study will investigate the effect of improved diet and nutrition on treatment offered to patients with IRD to provide more evidence-based knowledge, and thus specific dietary guidelines for patients with IRD. In addition, the study might increase the understanding of the role of omega-3 in the pathogenesis of inflammation.
The study is approved by the Regional Committee for Medical and Health Research Ethics. Participation is voluntary, and informed consent will be requested. Outpatients will be recruited by doctors at the Rheumatology Department at Haukeland University Hospital (HUH). Patients recruited will be included consecutively. The recruitment period will last up to 12 months. Anthropometrical measurements, analysis of body composition, blood tests, clinical parameters, and dietary data will be collected at baseline, and after 12, 24, 36 and 52 weeks.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's planned enrollment of 120 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diagnoses / conditions that make it difficult to follow a dietary intervention and / or supplementation of omega-3s, including:
0,9 gram omega-3/capsule x 4 = 3,6 gram omega-3 daily It will be investigated whether diet optimization followed with supplementation of omega-3s can reduce disease activity in patients with inflammatory arthritis. A new omega-3 high concentrate from GC Rieber Oils will be used
Dietary Supplement: Omega-3 · Behavioral: Dietary guidance
Soya oil
Dietary Supplement: Placebo (soya) · Behavioral: Dietary guidance
It will be investigated whether diet optimization and supplementation of omega-3s can reduce disease activity in patients with inflammatory arthritis. A new omega-3 high concentrate from GC Rieber Oils will be used.
Placebo (soya)
Dietary guidance
DAS28 (Disease Activity Score 28-joint count)
Disease activity score, higher values indicate a higher disease activity and below 2.6 meaning remission.
Time frame: Change between week 0, 12, 24, 36 and 52
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)
Disease activity score, higher values indicate a higher disease activity
Time frame: Change between week 0, 12, 24, 36 and 52
DAPSA (Disease Activity Index for Psoriatic Arthritis)
Disease activity score, higher values indicate a higher disease activity and below 4 meaning remission
Time frame: Change between week 0, 12, 24, 36 and 52
RAID (Rheumatoid Arthritis Impact of Disease)
Disease activity scores and scores evaluating quality of life, range 0-10, and higher scores indicate a higher grade of disability
Time frame: Change between week 0, 12, 24, 36 and 52
RAND12 (short form health survey)
Disease activity scores and scores evaluating quality of life
Time frame: Change between week 0, 12, 24, 36 and 52
MHAQ (Modified Health Assessment Questionnaire)
Disease activity scores and scores evaluating quality of life, range from 0 to 3 while higher values indicate a higher grade of disability
Time frame: Change between week 0, 12, 24, 36 and 52
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Disease activity scores and scores evaluating quality of life, range 0-10, and higher values indicate higher disease activity
Time frame: Change between week 0, 12, 24, 36 and 52
BASFI (Bath Ankylosing Spondylitis Functional Index)
Disease activity scores and scores evaluating quality of life, range 0-10, and higher values indicate a higher grade of disability
Time frame: Change between week 0, 12, 24, 36 and 52
CDAI (Clinical Disease Activity Index)
Disease activity scores and scores evaluating quality of life, range 0-76, and scores below 2.8 indicate remission
Time frame: Change between week 0, 12, 24, 36 and 52
Consumption of medicine after 12 months
The proportion who must start or change biological treatment, use of NSAIDs and steroids
Time frame: Change between baseline and week 52
BMI (Body Mass Index)
Nutritional status: Weight (kg) and height (m) will be combined to report BMI (kg/m\^2) Change in BMI, waist circumference, fat mass (kg), fat-free mass (kg), fat-free mass index (kg/m2), fat-mass index (kg/m2), handgrip strength
Time frame: Change between week 0, 12, 24, 36 and 52
Waist circumference
Nutritional status: Waist circumference (cm)
Time frame: Change between week 0, 12, 24, 36 and 52
Handgrip strength
Nutritional status: Handgrip strength, measured by a dynamometer (kg)
Time frame: Change between week 0, 12, 24, 36 and 52
Body composition
Estimation of fat mass (kg), fat-free mass (kg), measured by BIA and DXA. Fat-free mass index (kg/m2), and fat-mass index (kg/m2) will be calculated.
Time frame: Change between week 0, 12, 24, 36 and 52
Dietary intake of macro- and micronutrients, based on a dietary registration of 7 days
Energy (E%, kcal) proteins (g and E%) ratio of fatty acids fibers (g) Vitamins and minerals
Time frame: Week -1,10, 50
Dietary intake of macro- and micronutrients, based on a 24h recall.
Energy (E%, kcal) proteins (g and E%) ratio of fatty acids fibers (g) Vitamins and minerals
Time frame: Week 0, 12, 24, 36, 52
Blood lipid profile
HDL (mmol/L) LDL (mmol/L) total cholesterol (mmol/L) triglycerides (mmol/L)
Time frame: Change from week 0, 12, 24, 36 and 52
Plan to share: Yes — Individual participant data that underlie the results reported in articles will be shared, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Haukeland University Hospital