Lupus & antiphospholipid syndrome
Clinical and serological association of plasma 25-hydroxyvitamin D (25(OH)D) levels in lupus and the short-term effects of oral vitamin D supplementation
Authors' conclusion
Vitamin D deficiency is common in SLE. Geographical location of residence is the major determinant rather than the disease activity. The IFN regulated proteins reflect disease activity independent of vitamin D levels. High-dose oral vitamin D supplementation seems safe and more effective in improving vitamin D levels in SLE.
Study context
- Population
- Patients with systemic lupus erythematosus (SLE) from north and south India; phase II: SLEDAI-2KG < 10 and on stable immunosuppressionphase I
- Participants
- 702 patients
- Comparison
- Phase II: high-dose vs routine-dose oral vitamin D
Methodological detailstwo-phase study, phase I cross-sectional analytical, phase II randomised, multicentre (north and south India)
- Two-phase study
- Phase I cross-sectional analytical
- Phase II randomised
- Multicentre (north and south India)
Primary result
As reported in the abstract
Median plasma vitamin D, ng/ml (IQR as printed)
22.83
13.8–31.8
Deficiency (< 20 ng/ml)
41.5%
Predictors on multiple linear regression (p < 0.05): centre of recruitment
β = 4.37
Predictors on multiple linear regression (p < 0.05): age
β = 0.18
Further findings
Median, ng/ml
| Outcome | High dose | Routine dose | P value |
|---|---|---|---|
| Plasma vitamin D by region (phase I)South India vs North India | P < 0.01 | ||
| Median change in plasma vitamin D (phase II) · 6 months | 9.5 | 2.6 | P = 0.04 |
- Plasma vitamin D by region (phase I): South India 27.06 ± 20.21 ng/dl
- Plasma vitamin D by region (phase I): North India 17.15 ± 16.07 ng/ml
Correlations (phase I, univariate)
- Weak negative correlation of vitamin D with SLEDAI-2K and positive correlation with age
- Galectin-9 modestly correlated with SLEDAI-2K but not with vitamin D
Safety
SLE flares and minor adverse events (phase II) · 6 months
- SLE flares, equal across both groups
- 14
- Minor adverse events, equal across both groups
- 6
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →