SpondyloarthritisEROMNCT04586933
Nutrition in Rheumatic Diseases
A study testing Omega-3 and Dietary guidance in people with Spondyloarthritis and Rheumatoid Arthritis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spondyloarthritis, Rheumatoid Arthritis, Polyarthritis
- What is being tested?
- Omega-3 and Dietary guidance
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 10 Dec 2020to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be diagnosed with one of the following diagnoses: rheumatoid arthritis, according to the ACR / EULAR 2010 criteria, psoriatic arthritis, according to the CASPAR criteria, axial spondylarthritis, including ankylosing spondylarthritis and non-radiographic spondylarthritis, according to the ASAS criteria
- Duration of illness ≥0.5 years
- Between 18 and 75 years
- Understand Norwegian
- The patient has given informed consent to participate
- No change in medication the last 12 weeks before inclusion
Who cannot join
- Diagnoses / conditions that make it difficult to follow a dietary intervention and / or supplementation of omega-3s, including:
- Conditions or use of medications where omega-3 is contraindicated
- Pregnancy / lactation
- Allergy to soy or fish
- Severe liver disease
- Severe mental or physical illnesses, such as insulin-requiring diabetes
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestland, 5021
Anne-Kristine H. Halse, MD, PhD, 004755975434, anne.kristine.hjorteseth.halse@helse-bergen.no
Randi J. Tangvik, CD Ass Prof
About this study
Official title: Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Spondyloarthritis, Rheumatoid Arthritis, Polyarthritis
- Being tested
- Omega-3, Placebo (soya), Dietary guidance
- Keywords
- Fatty acids, Diet, Nutritional Status
- Medical subject headings
- Spondylarthritis, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
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 supplement
Placebo (soya)
Dietary guidanceBehavioural
Dietary guidance
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Active comparator | 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 Receives: Dietary Supplement: Omega-3; Behavioral: Dietary guidance |
| Placebo capsules | Placebo comparator | Soya oil Receives: Dietary Supplement: Placebo (soya); Behavioral: Dietary guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28 (Disease Activity Score 28-joint count)
Disease activity score, higher values indicate a higher disease activity and below 2.6 meaning remission.
Measured: 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
Measured: 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
Measured: Change between week 0, 12, 24, 36 and 52
Secondary outcomes (14)
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
Measured: Change between week 0, 12, 24, 36 and 52
RAND12 (short form health survey)
Disease activity scores and scores evaluating quality of life
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change between week 0, 12, 24, 36 and 52
Waist circumference
Nutritional status: Waist circumference (cm)
Measured: Change between week 0, 12, 24, 36 and 52
Handgrip strength
Nutritional status: Handgrip strength, measured by a dynamometer (kg)
Measured: 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.
Measured: 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
Measured: 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
Measured: Week 0, 12, 24, 36, 52
Blood lipid profile
HDL (mmol/L) LDL (mmol/L) total cholesterol (mmol/L) triglycerides (mmol/L)
Measured: Change from week 0, 12, 24, 36 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start10 Dec 2020
- Primary completion10 Jun 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be twofold and consist of Intervention 1 and Intervention 2. Intervention 1: Dietary guidance (12 weeks). All participants will receive individual dietary guidance, as well as an intensive dietary course with 4 sessions. Participants will receive contact information to the clinical dietitian, and the opportunity to ask questions throughout the intervention period. Patients will be asked to not use other omega-3 supplement during the intervention period 1. Intervention 2: Omega-3 vs. placebo (24 weeks). After intervention 1, patients will be randomized to take either 3 grams of omega-3 or placebo daily, divided into 4 capsules. Patients will be asked not to use other omega-3 supplements in the period from 2 months until after intervention period 2.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GC Rieber Oils AS
- Responsible party
- Sponsor
- Investigators
- Anne-Kristine H Halse, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586933
- Sponsor's protocol ID
- 79907
- Acronym
- EROM
- Status last verified
- Jan 2023
- First submitted
- 22 Sep 2020
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in articles will be shared, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance
- ClinicalTrials.gov ID
- NCT04586933
- Acronym / sponsor ID
- EROM / 79907
- Conditions
- Spondyloarthritis, Rheumatoid Arthritis, Polyarthritis
- Keywords
- Fatty acids, Diet, Nutritional Status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- GC Rieber Oils AS
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Jun 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be twofold and consist of Intervention 1 and Intervention 2. Intervention 1: Dietary guidance (12 weeks). All participants will receive individual dietary guidance, as well as an intensive dietary course with 4 sessions. Participants will receive contact information to the clinical dietitian, and the opportunity to ask questions throughout the intervention period. Patients will be asked to not use other omega-3 supplement during the intervention period 1. Intervention 2: Omega-3 vs. placebo (24 weeks). After intervention 1, patients will be randomized to take either 3 grams of omega-3 or placebo daily, divided into 4 capsules. Patients will be asked not to use other omega-3 supplements in the period from 2 months until after intervention period 2.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Active comparator | Dietary Supplement: Omega-3, Behavioral: Dietary guidance0,9 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 |
| Placebo capsules | Placebo comparator | Dietary Supplement: Placebo (soya), Behavioral: Dietary guidanceSoya oil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be diagnosed with one of the following diagnoses: rheumatoid arthritis, according to the ACR / EULAR 2010 criteria, psoriatic arthritis, according to the CASPAR criteria, axial spondylarthritis, including ankylosing spondylarthritis and non-radiographic spondylarthritis, according to the ASAS criteria
- Duration of illness ≥0.5 years
- Between 18 and 75 years
- Understand Norwegian
- The patient has given informed consent to participate
Key exclusion criteria (6 listed)
- Diagnoses / conditions that make it difficult to follow a dietary intervention and / or supplementation of omega-3s, including:
- Conditions or use of medications where omega-3 is contraindicated
- Pregnancy / lactation
- Allergy to soy or fish
- Severe liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3It 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. | Dietary supplement | Omega-3 |
| Placebo (soya)Placebo (soya) | Dietary supplement | Placebo capsules |
| Dietary guidanceDietary guidance | Behavioural | Omega-3, Placebo capsules |
Primary outcome
DAS28 (Disease Activity Score 28-joint count)
Time frame: Change between week 0, 12, 24, 36 and 52
Disease activity score, higher values indicate a higher disease activity and below 2.6 meaning remission.
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)
Time frame: Change between week 0, 12, 24, 36 and 52
Disease activity score, higher values indicate a higher disease activity
DAPSA (Disease Activity Index for Psoriatic Arthritis)
Time frame: Change between week 0, 12, 24, 36 and 52
Disease activity score, higher values indicate a higher disease activity and below 4 meaning remission
14 secondary outcomes
RAID (Rheumatoid Arthritis Impact of Disease)
Time frame: Change between week 0, 12, 24, 36 and 52
RAND12 (short form health survey)
Time frame: Change between week 0, 12, 24, 36 and 52
MHAQ (Modified Health Assessment Questionnaire)
Time frame: Change between week 0, 12, 24, 36 and 52
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: Change between week 0, 12, 24, 36 and 52
BASFI (Bath Ankylosing Spondylitis Functional Index)
Time frame: Change between week 0, 12, 24, 36 and 52
CDAI (Clinical Disease Activity Index)
Time frame: Change between week 0, 12, 24, 36 and 52
Consumption of medicine after 12 months
Time frame: Change between baseline and week 52
BMI (Body Mass Index)
Time frame: Change between week 0, 12, 24, 36 and 52
Waist circumference
Time frame: Change between week 0, 12, 24, 36 and 52
Handgrip strength
Time frame: Change between week 0, 12, 24, 36 and 52
Body composition
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
Time frame: Week -1,10, 50
Dietary intake of macro- and micronutrients, based on a 24h recall.
Time frame: Week 0, 12, 24, 36, 52
Blood lipid profile
Time frame: Change from week 0, 12, 24, 36 and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in articles will be shared, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Kristine H Halse, MD, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 and Dietary guidance in people with Spondyloarthritis and Rheumatoid Arthritis, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie N Olsen, Msc (0047-95802404, marienjerve@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28 (Disease Activity Score 28-joint count) (time frame: Change between week 0, 12, 24, 36 and 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.