SLE Clinical Trial
Official title:
Effect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-β1 (TGF-β1) Serum
This a double blind randomised controlled trial (RCT) to determine the effect of Curcuma Xanthorrhiza supplementation on vitamin D3 administration to disease activity (SLEDAI), IL-6 and TGF-β1 serum in SLE patients with hypovitamin D. SLE patients with hypovitamin D had milder disease activity, lower IL-6 and higher TGF-β1 serum level when supplemented with Curcuma Xanthorrhiza and vitamin D3 compared with vitamin D3 and placebo.
Cholecalciferol 1200 IU supplementation for 3 months in hypovitamin D SLE patients, decrease
SLEDAI, however, it has not reached the mild activity and remission yet. Curcumin contained
in Curcuma Xanthorrhiza; is an immunomodulator that has similar biological effect with
vitamin D. Combination of curcumin and vitamin D are expected to work synergistically.
The subjects who fulfilled inclusion criteria, willing to participate in the research and
signed the informed consent were 40 patients. Research subjects were randomized using simple
randomization. The subjects were divided into 2 groups: the group receiving 3×400 IU
cholecalciferol and 3×1 tablet placebo (group I, n=20), and the group receiving 3×400 IU and
curcumin (Curcuma Xanthorrhiza) 3x20 mg for 3 months (group II, n=20).
Fifteen cc of venous blood samples were taken for complete blood tests, liver function
(SGOT/SGPT), renal function (ureum/creatinine), vitamin D (25(OH)D), calcium, anti-dsDNA,
C3, C4, IL-6 and serum TGF-β1. Examination of vitamin D levels using Enzyme Immuno Assay
method (Diasorin Inc, Stillwater, MN USA), anti-dsDNA levels using ELISA
(Bioluminescenassay), C3, C4, IL-6 and serum TGF-β1 using ELISA (Biolegend). Proteinuria was
examined using a urine spot sample while with enzymatic-turbidimetric methods. SLE disease
activity was assessed using SLEDAI score. Laboratory and SLEDAI examination were performed
at the beginning of the study and the end of the study; except for the serum calcium levels
examined each month to determine the side effects of the drug.
Patients continue to receive the usual immunosuppressive drugs (corticosteroids,
chloroquine, cyclophosphamide, mycophenolate mofetil, azathioprine, and cyclosporine), as
well as calcium, antihypertensive drugs and other routine medications. Regular drugs,
cholecalciferol, Curcuma Xanthorrhiza and placebo, are administered by a physician in the
Rheumatology Outpatient Clinic who is not a member of the research team in different
examination rooms.
The results are presented in mean ± standard deviation, median (IQR 25-75%) and n (%). The
homogeneity test of variance using Levene. The Saphiro-Wilk test is used to determine the
normality of the data, assuming the normality of the data is fulfilled if p> 0.05. Different
tests after treatment in both study groups used a non-paired/Mann-Whitney test. The
influence between variables was tested using Spearman/Pearson correlation test. Data
analysis uses Statistical Package for the Social Sciences Software version 22 (SPSS Inc,
Chicago IL). Differences and correlations are said to be significant when the value of p
<0.05.
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