Nutrition in Rheumatic Diseases

NCT04586933 | Unknown

• 1 other identifier: 79907
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spondyloarthritis; Rheumatoid Arthritis; Polyarthritis

Keywords

Fatty acids; Diet; Nutritional Status

Outcome Measures

Primary Outcomes (3)

• DAS28 (Disease Activity Score 28-joint count)

  Disease activity score, higher values indicate a higher disease activity and below 2.6 meaning remission.

  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

  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

  Change between week 0, 12, 24, 36 and 52

Secondary Outcomes (14)

• RAID (Rheumatoid Arthritis Impact of Disease)

  Change between week 0, 12, 24, 36 and 52

• RAND12 (short form health survey)

  Change between week 0, 12, 24, 36 and 52

• MHAQ (Modified Health Assessment Questionnaire)

  Change between week 0, 12, 24, 36 and 52

• BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)

  Change between week 0, 12, 24, 36 and 52

• BASFI (Bath Ankylosing Spondylitis Functional Index)

  Change between week 0, 12, 24, 36 and 52

Study Arms (2)

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

Dietary Supplement: Omega-3; Behavioral: Dietary guidance

Placebo capsules

PLACEBO COMPARATOR

Soya oil

Dietary Supplement: Placebo (soya); Behavioral: Dietary guidance

Interventions

Omega-3 DIETARY_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.

Omega-3

Placebo (soya) DIETARY_SUPPLEMENT

Placebo (soya)

Placebo capsules

Dietary guidance BEHAVIORAL

Dietary guidance

Omega-3; Placebo capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• GC Rieber Oils AS: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Spondylarthritis; Arthritis, Rheumatoid; Arthritis

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Anne-Kristine H Halse, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie N Olsen, Msc

CONTACT

0047-95802404; marienjerve@gmail.com

Anne-Kristine H Halse, MD, PhD

CONTACT

0047-95883957; anne-kristine.halse@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 14, 2020
• Study Start: December 10, 2020
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available from 9 months and ending 36 months following article publication.
• Access Criteria: IPD will be shared with investigators who provide a methodologically sound proposal, and whose use of data has been approved by a Human Subjects Protection Review Board. Proposal can be directed to marienjerve@gmail.com

Locations

NO (1)