Nutrition in Rheumatic Diseases
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Polyarthritis
- Rheumatoid Arthritis
- Spondyloarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 inclu...
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.
Tracking Information
- NCT #
- NCT04586933
- Collaborators
- GC Rieber Oils AS
- Investigators
- Principal Investigator: Anne-Kristine H Halse, MD, PhD Haukeland University Hospital
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