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NUTRANCT06831331

Nutrition in Rheumatoid Arthritis

StatusEnrolling by Invitation
PhaseNot applicable
Primary completion (estimated)

At risk: Primary endpoint(s) modified, enrollment reduced 20%.

See at-risk trials from Vastra Gotaland Region

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Record History

All 4 versions: 3 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Enrollment reduced: 150 → 120 participants
    • Interventions modified
    • Secondary endpoints revised (13)
    • Study description shortened, about 326 words
    • Eligibility criteria expanded, about 1 word
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Secondary endpoints: details revised at 2 of 13 entries
    • Site contact updated
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Apolipoprotein B
Timeframe: 3 months dietary intervention and at 9 months follow up

Secondary (13)

Patterns of serum inflammatory markers
Remission yes/no
Disease activity DAS28-CRP
triacylglycerides
high density lipoprotein
Show 8 moreShow less
Low density lipoprotein (LDL)
total cholesterol
Erythrocyte sediment rate (ESR)
high sensitive-C-reactive protein (hs-CRP)
Corticosteroid use
Physical disability
Quality of life (RAND-SF36)
Disease activity score DAS28-ESR

Arms and interventions

Immediate healthy diet intervention based on the NNR 2023Experimental

Diet following the Nordic Nutrition Recommendations 2023

Delayed dietary intervention based on the NNR2023 (waiting-list control)Experimental

Habitual diet for 3 months followed by healthy diet based on NNR2023 for 3 months

Other: Healthy diet based on NNR2023, Control/waiting-list

Sites

1 site in 1 country

  • Klinisk Reumatologiskt Forskningscentrum, Sahlgrenska University HospitalGothenburg, Sweden