Table 2.
Author & year | Design | N | Patients + location | Dose | Outcome | Result |
---|---|---|---|---|---|---|
Ruiz-Irastorza et al., 2010 [72] | Longitudinal Observational (prospective- cohort) Single center |
80 | SLE Spain |
600–800iu/day 24 months |
SLEDAI SDI Fatigue (VAS) |
Fatigue: VAS, 4.1 versus 3.3 P = 0.015. SLEDAI: No effect SDI: No effect |
Terrier et al., 2012 [73] | Single center Open-label |
20 | SLE France |
100,000Iu weekly for 4 weeks, then 100,000 monthly for 6 months |
Safety SLEDAI B cells T cells Cytokines |
SLEDAi: 2.9 ± 2.5 to 2.6 ± 2.5 at 2 months, non significant. Anti dsDNA: Decreased at 2 and 6 months. CD4: Non significant increase CD*: Decreased in frequency but not in number. T regs: Increased |
Petri et al., 2013 [74] | Longitudinal Cohort |
1006 | SLE USA (37% African American) |
50,000 iu weekly + 400 iu calcium/vitamin D daily |
SLEDAI Physician global (0 –3) UPCR |
SLEDAI: Significant decrease. Physician global: Improved significantly UPCR: 20-ng/ml increase in the 25(OH)D value was associated with a 4% decrease in UPCR |
Abou-Raya et al., 2013 [75] | Randomized (2:1) | 267 | SLE Egypt |
2000iu daily/placebo | SLEDAI | SLEDAI: Correlated negatively with vitamin D. SLEDAI improved with supplementation. |
Andreoli et al., 2015 [77] | Randomized Unblinded |
34 | SLE Italy |
300,000 bolus, 50,000iu monthly compared with |
T cell and B cell populations |
Promotion of regulatory T cells Production of Th2 cytokines |
Piantoni et al., 2015 [147] (reported in two parts) |
25,000iu monthly | SLE serology | Serology: Unchanged | |||
Arno w et al., 2015 [63] | Randomized Double blind Placebo controlled |
54 | SLE USA (54% African American) |
2000iu, 4000iu/placebo | Interferon signature |
No effect on interferon signature |
Lima et al., 2015 [76] | Randomized Double blind Placebo controlled |
50 | Juvenile SLE Brazil (30% non- caucasian) |
50,000 iu weekly versus placebo |
K-FSS SLEDAI ECLAM |
SLEDAI: Improved (P = 0.01) ECLAM: Improved (P = 0.006) |
SLEDAI: SLE disease activity index, SDI: ACR/SLICC damage index, UPCR: Urine protein to Creatinine ratio, VAS: visual analogue scale, ECLAM: European Consensus Lupus Activity Measurement, K-FSS: Kids fatigue severity scale.