An interventional study of "Cholecalciferol" and "C. Xanthorrhiza" and "Cholecalciferol" and "placebo" in SLE, sponsored by Saiful Anwar Hospital. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Saiful Anwar Hospital · Not applicable, Interventional, and Treatment
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.
1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 39 is below the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.
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Exclusion Criteria:
Subjects received Cholecalciferol 400 IU 3 times daily and C. Xanthorrhiza 20 mg 3 times daily per oral for 3 months (group II, n=19)
Dietary Supplement: "Cholecalciferol" and "C. Xanthorrhiza"
Subjects received cholecalciferol 3×400 IU and placebo 3×1 tablet for 3 months (group I, n=20).
Dietary Supplement: "Cholecalciferol" and "placebo"
Cholecalciferol are given 400 IU 3 times daily for 3 months C. Xanthorrhiza are given 200 mg 3 times daily for 3 months
Also known as: Teorol 400 IU Novell Pharmaceutical Laboratories, Curcuma Soho Industries Pharmacy
Cholecalciferol are given 400 IU 3 times daily for 3 months Placebo are given 3 times daily for 3 months
Also known as: Teorol 400 IU Novell Pharmaceutical Laboratories
SLE disease activity
SLE disease activity was assessed using SLEDAI in the last 10 days
Time frame: 3 months
IL-6
IL-6 serum level (pg/ml)
Time frame: 3 months
TGF-β1
TGF-β1 serum level (pg/ml)
Time frame: 3 months
No study locations are listed for this record.
Plan to share: Undecided
Ran from Jun 2016 to primary completion in Mar 2017, 9 months.
Of 120 non-industry interventional studies with no phase under Lupus Erythematosus, Systemic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 9 months is below that.
Counting every sponsor, half of 127 studies reached it within 22 months; a quarter within 10 and three quarters within 37.
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Saiful Anwar Hospital