Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin D
Condition: SLE
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): "Cholecalciferol" and "C. Xanthorrhiza"; "Cholecalciferol" and "placebo"
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cholecalciferol are given 400 IU 3 times daily for 3 months C. Xanthorrhiza are given 200 mg 3 times daily for 3 months; Cholecalciferol are given 400 IU 3 times daily for 3 months Placebo are given 3 times daily for 3 months
Other intervention name(s): Teorol 400 IU Novell Pharmaceutical Laboratories; Curcuma Soho Industries Pharmacy; Teorol 400 IU Novell Pharmaceutical Laboratories
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SLE, vitamin D, SLEDAI, IL-6, TGF- β1