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Randomized Controlled Trial
. 2023 May 1;159(5):518-525.
doi: 10.1001/jamadermatol.2023.0357.

Effect of Vitamin D Supplementation on Psoriasis Severity in Patients With Lower-Range Serum 25-Hydroxyvitamin D Levels: A Randomized Clinical Trial

Affiliations
Randomized Controlled Trial

Effect of Vitamin D Supplementation on Psoriasis Severity in Patients With Lower-Range Serum 25-Hydroxyvitamin D Levels: A Randomized Clinical Trial

Marita Jenssen et al. JAMA Dermatol. .

Erratum in

  • Error in Table 1.
    [No authors listed] [No authors listed] JAMA Dermatol. 2024 Nov 1;160(11):1257. doi: 10.1001/jamadermatol.2024.4210. JAMA Dermatol. 2024. PMID: 39356514 Free PMC article. No abstract available.
  • Error in Box.
    [No authors listed] [No authors listed] JAMA Dermatol. 2025 May 1;161(5):562. doi: 10.1001/jamadermatol.2025.0619. JAMA Dermatol. 2025. PMID: 40136288 Free PMC article. No abstract available.

Abstract

Importance: Topical vitamin D analogues are routine treatment for psoriasis, but the effect of oral supplementation has not been established.

Objective: To examine the effect of vitamin D supplementation on psoriasis severity throughout the winter.

Design, setting, and participants: This randomized, double-blind placebo-controlled clinical trial with 2 parallel groups was performed through 2 winter seasons (2017 to 2018 and 2018 to 2019). Randomization was computer generated. All participants, health care clinicians, and outcome assessors were masked to group assignment. Each participant was followed for 4 months. The presented analyses were conducted in May 2022. The trial was conducted at the clinical research unit of the University Hospital of North Norway (Tromsø; Norway). Adults from the general population in Tromsø with active plaque psoriasis and 25-hydroxyvitamin D (25[OH]D) levels of less than 24 ng/mL (to convert to nmol/L, multiply by 2.496) were included.

Intervention: Vitamin D (cholecalciferol, 100 000 IU, loading dose, followed by 20 000 IU/week) or placebo for 4 months.

Main outcomes and measures: Psoriasis Area Severity Index (PASI) (primary outcome), Physician Global Assessment, self-administered PASI, and Dermatology Life Quality Index scores (secondary outcomes).

Results: A total of 122 participants (46 women [37.7%]; mean [SD] age, 53.6 [10.0] years; mean [SD] PASI score, 3.1 [2.0]; mean [SD] serum 25(OH)D, 14.9 [3.9] ng/mL) were included. Of these, 60 (49.2%) were randomized to the vitamin D group and 62 (50.8%) to the placebo group. A total of 120 participants (59 vitamin D [49.2%]/61 placebo [51.8%]) completed the study. By completion, mean (SD) 25(OH)D levels were 29.7 (5.2) ng/mL (vitamin D) and 12.0 (3.8) ng/mL (placebo). There was no significant difference in change in PASI score between the groups (adjusted difference, 0.11; 95% CI, -0.23 to 0.45). There was no significant difference in change in Physician Global Assessment score (adjusted odds ratio, 0.66; 95% CI, 0.27-1.63), self-administered PASI (adjusted difference, -0.60; 95% CI, -1.76 to 0.55) or Dermatology Life Quality Index (adjusted difference, -0.86; 95% CI, -1.9 to 0.19) between the groups. No adverse effects of the intervention were registered.

Conclusion and relevance: The results of this randomized clinical trial showed that vitamin D supplementation did not affect psoriasis severity. Low baseline severity scores may explain the lack of measurable effect. Levels of 25(OH)D in the intervention group increased to a less-than-expected degree based on previous experimental data from the same source population, and this may have affected the results.

Trial registration: ClinicalTrials.gov Identifier: NCT03334136.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Jenssen reported grants from Northern Norway Regional Health Authority and the Odd Berg Medical Research Foundation during the conduct of the study. Dr Danielsen reported grants from the Northern Norway Regional Health Authority and Odd Berg Medical Research Foundation during the conduct of the study as well as advisor fees from Leo Pharma, Galderma, Novartis, AbbVie, UCB Pharma, Almirall, Celgene, Bristol Myers Squibb, and Meda Pharma outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. CONSORT Flow Diagram

References

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