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High- vs. routine-dose vitamin D3 in severe lupus on pulse methylprednisolone: a randomized, double-blind, placebo-controlled clinical trial.

  • 2025-08-16
  • Clinical rheumatology 44(10)
    • Lisbeth A Aguila
    • Rosa M R Pereira
    • Luciana P Seguro
    • Michelle R Ugolini-Lopes
    • Lissiane K N Guedes
    • Lucas P Sales
    • Alan L Fernandes
    • Felipe M de Santana
    • Valéria F Caparbo
    • Liliam Takayama
    • Eduardo F Borba
    • Diogo S Domiciano

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 20
Population
40 SLE inpatients receiving intravenous pulse methylprednisolone
Methods
Randomized, double-blind, placebo-controlled trial; high-dose (100,000 IU vitamin D3 plus 7000 IU weekly) vs routine-dose (placebo plus 7000 IU weekly) for 24 weeks
Blinding
Double-blind
Duration
24 weeks
Funding
Unclear

Introduction/objectives

This study evaluated high- vs. routine-dose vitamin D3 in severe SLE patients on high-dose glucocorticoids, an underrepresented group in research.

Methods

In a randomized, double-blind, placebo-controlled trial, 40 SLE inpatients receiving intravenous pulse methylprednisolone were assigned to "high-dose" (HD) (100,000 IU of vitamin D3 plus 7000 IU weekly, n = 20) or "routine-dose" (RD) vitamin D3 group (placebo plus 7000 IU weekly, n = 20) for 24 weeks. Changes in disease activity were assessed from baseline to study end.

Results

Baseline SLEDAI scores were comparable between the HD group (median 19) and the RD group (median 14.5; p = 0.230). After 24 weeks, the HD group had a significantly greater increase in 25OHD concentrations (median 15.4 ng/ml) compared to the RD group (median 8.0 ng/ml; p = 0.028). No difference in SLEDAI scores was observed; however, there was a trend toward a greater ΔC4 increase in the HD group (7.38 vs. 3.27, p = 0.093). Δ25OHD showed positive correlations with disease activity markers. ROC analysis identified Δ25OHD cutoffs of 12.9 ng/ml (AUC = 0.741) for C3 and 11.7 ng/ml (AUC = 0.757) for C4 normalization, indicating that exceeding these may improve complement normalization.

Conclusions

Although SLEDAI scores did not differ between groups, high-dose vitamin D3 led to greater increases in 25OHD levels and showed trends toward improved serological markers. These exploratory findings suggest potential biological effects and support the safety and feasibility of high weekly doses (up to 100,000 IU), warranting further investigation in severe SLE.

Research Insights

  • Vitamin D→Increased 25-hydroxyvitamin D Level

    After 24 weeks, the HD group had a significantly greater increase in 25OHD concentrations (median 15.4 ng/ml) compared to the RD group (median 8.0 ng/ml; p = 0.028).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    High-dose group: 100,000 IU vitamin D3 plus 7,000 IU weekly
  • Vitamin D→Increased Complement C3 Level

    ROC analysis identified Δ25OHD cutoffs of 12.9 ng/ml (AUC = 0.741) for C3 ... normalization, indicating that exceeding these may improve complement normalization.

    Effect
    Neutral
    Effect size
    Small
    Dose
    High-dose group: 100,000 IU vitamin D3 plus 7,000 IU weekly; Routine-dose group: placebo plus 7,000 IU weekly
  • Vitamin D→Increased Complement C4 Level

    there was a trend toward a greater ΔC4 increase in the HD group (7.38 vs. 3.27, p = 0.093)

    Effect
    Neutral
    Effect size
    Small
    Dose
    High-dose group: 100,000 IU vitamin D3 plus 7,000 IU weekly; Routine-dose group: placebo plus 7,000 IU weekly
  • Vitamin D→Reduced Systemic Lupus Erythematosus Disease Activity Index Score

    No difference in SLEDAI scores was observed

    Effect
    Neutral
    Effect size
    Small
    Dose
    High-dose group: 100,000 IU vitamin D3 plus 7,000 IU weekly; Routine-dose group: placebo plus 7,000 IU weekly
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