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.
Study Goal
The researchers aimed to determine the association of vitamin D levels with clinical phenotype and disease activity in SLE patients and evaluate the short-term effects of two different oral vitamin D supplementation regimens on disease flares and plasma vitamin D levels.
Results Summary
Vitamin D deficiency was common in SLE patients, with geographical location being a major determinant of levels. High-dose vitamin D supplementation was more effective in improving vitamin D levels compared to routine dosing, with no significant difference in adverse events or flares between the two groups.
Population
702 systemic lupus erythematosus (SLE) patients from North and South India.
Effective Dosage
High dose (weekly 60,000 U for 5 weeks, then 60,000 U monthly) and routine dose (30,000 U monthly).
Duration
6 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
- | increase | vitamin D levels | Patients from South India | 27.06 ± 20.21 ng/dl versus 17.15 ± 16.07 ng/ml | had higher | #1 |
- | decrease | vitamin D with SLEDAI2K | patients with SLE | - | demonstrated weak negative correlation | #2 |
- | increase | vitamin D with age | patients with SLE | - | positive correlation | #3 |
- | increase | Galactin-9 with SLEDAI2K | patients with SLE | - | modest correlation | #4 |
- | no change | Galactin-9 with vitamin D levels | patients with SLE | - | not with | #5 |
high dose oral vitamin D supplementation | increase | median change in plasma vitamin D levels | patients with SLE | 9.5 versus 2.6 ng/ml | was more | #6 |
high-dose oral vitamin D supplementation | increase | vitamin D levels | patients with SLE | - | seems safe and more effective in improving | #7 |
BACKGROUND AND OBJECTIVES: Data on the association of vitamin D levels and clinical phenotype and disease activity in systemic lupus erythematosus (SLE) is controversial. Further, the optimal dose of oral vitamin D supplementation in SLE is not clear. Thus, the present study was designed to determine the association of plasma vitamin D levels with clinical phenotype, disease variables and serology in a large, cohort of SLE from South Asia and to evaluate the short-term effect of two different dosage regimens of oral vitamin D supplementation on disease flares and plasma vitamin D levels. METHODS: This is a two-phase study. Phase I was a cross-sectional analytical study of patients from north (26.85° N) and south India (11.94° N). Plasma 25-hydroxyvitamin-D(25(OH)D) was measured, and its association with demography, serology, disease activity, Galectin-9 and CXCL-10 was analysed. In phase II, patients with SLEDAI-2KG < 10 and on stable immunosuppression were randomised to receive either high dose (weekly 60,000 U*5, followed by 60,000 U monthly) or routine dose (30,000 U monthly) oral vitamin D. Outcomes were assessed at 6 months RESULTS: Phase I included 702 patients with a mean age of 29.46 + 10.7 years. The median plasma vitamin D was 22.83 (13.8-31.8) ng/ml. Deficiency (< 20 ng/ml) was seen in 41.5% of patients. Patients from South India had higher vitamin D levels (27.06 ± 20.21 ng/dl) as compared to North India (17.15 ± 16.07 ng/ml) (p < 0.01). Univariate analyses demonstrated weak negative correlation of vitamin D with SLEDAI2K and positive correlation with age. Galactin-9 had modest correlation with SLEDAI2K but not with vitamin D levels. On multiple linear regression, centre of recruitment (β = 4.37) and age (β = 0.18) predicted (p < 0.05) plasma vitamin D levels. In the phase II, 91 randomised to 2 groups completed 6 months. Median change in plasma vitamin D levels was more in high dose (9.5 versus 2.6 ng/ml; p = 0.04). There were 14 SLE flares and six minor adverse events which were equal across both groups. 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. TRIAL REGISTRATION: The second phase of this study was a registered randomised controlled trial CTRI/2019/06/019658 [registered on: 14/06/2019].