Across rheumatic diseases

Vitamin D and Marine n‐3 Fatty Acids for Autoimmune Disease Prevention: Outcomes Two Years After Completion of a Double‐Blind, Placebo‐Controlled Trial

Arthritis RheumatolPublished Post-trial observational follow-up of the VITAL randomised controlled trial

Authors' conclusion

Two years after trial termination, the protective effects of 2000 IU/day of vitamin D dissipated, but 1,000 mg/day of n-3 fatty acids had a sustained effect in reducing AD incidence.

Study context

Population
Men aged ≥50 and women aged ≥55 initially randomized in VITAL; surviving and willing participants observed for two more yearsobserved for two more years (83.5%)
Participants
21,592 men
Comparison
Vitamin D vs placebo and n-3 fatty acids vs placebo
Primary endpoint
All confirmed incident AD
Follow-up
7 years
Methodological details2 × 2 factorial, double-blind, placebo-controlled, two years of postintervention observation
  • 2 × 2 factorial
  • Double-blind
  • Placebo-controlled
  • Two years of postintervention observation

Primary result

As reported in the abstract

Incident confirmed AD

Vitamin D

255

events

Vitamin D placebo

259

events

n-3 fatty acids

234

events

n-3 placebo

280

events

Hazard ratio (95% CI)
Vitamin Dvs Vitamin D placebo
0.98(0.83–1.17)
n-3 fatty acidsvs n-3 placebo
0.83(0.70–0.99)

Secondary outcomes

OutcomeHR (95% CI)
Incident AD during randomized period, including 65 newly confirmed cases with onset during randomizationVitamin Dvs Vitamin D placebo0.85 (0.70–1.04)
Incident AD during randomized period, including 65 newly confirmed cases with onset during randomizationn-3 fatty acidsvs n-3 placebo0.87 (0.71–1.06)

Original publication

Vitamin D and Marine n‐3 Fatty Acids for Autoimmune Disease Prevention: Outcomes Two Years After Completion of a Double‐Blind, Placebo‐Controlled Trial. Arthritis Rheumatol. Published 20 February 2024. doi:10.1002/art.42811

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