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Trial record 27 of 111 for:    Turmeric

Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin D

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ClinicalTrials.gov Identifier: NCT03155477
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Cameleia Diah Setyorini, Saiful Anwar Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
SLE Dietary Supplement: "Cholecalciferol" and "C. Xanthorrhiza" Dietary Supplement: "Cholecalciferol" and "placebo" Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 10, 2016
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : March 13, 2017


Arm Intervention/treatment
Experimental: "Cholecalciferol" and "C. Xanthorrhiza"
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"
Cholecalciferol are given 400 IU 3 times daily for 3 months C. Xanthorrhiza are given 200 mg 3 times daily for 3 months
Other Names:
  • Teorol 400 IU Novell Pharmaceutical Laboratories
  • Curcuma Soho Industries Pharmacy

Placebo Comparator: "Cholecalciferol" and "placebo"
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 Placebo are given 3 times daily for 3 months
Other Name: Teorol 400 IU Novell Pharmaceutical Laboratories




Primary Outcome Measures :
  1. SLE disease activity [ Time Frame: 3 months ]
    SLE disease activity was assessed using SLEDAI in the last 10 days


Secondary Outcome Measures :
  1. IL-6 [ Time Frame: 3 months ]
    IL-6 serum level (pg/ml)

  2. TGF-β1 [ Time Frame: 3 months ]
    TGF-β1 serum level (pg/ml)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SLE based on the criteria of American Collage of Rheumatology (ACR) 1997
  • Active SLE (SLEDAI> 3)
  • 25(OH)D level <30 ng/ml.

Exclusion Criteria:

  • Pregnant
  • Taking supplements containing vitamin D and cur cumin
  • Had liver function disorders (SGOT/SGPT levels> 2.5 times the upper normal limit)
  • Had impaired renal function (GFR <25 ml/min)
  • Severe infections such as tuberculosis, pneumonia or HIV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155477


Sponsors and Collaborators
Saiful Anwar Hospital
Investigators
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Principal Investigator: Handono Kalim, Prof.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cameleia Diah Setyorini, Medical Doctor, Saiful Anwar Hospital
ClinicalTrials.gov Identifier: NCT03155477     History of Changes
Other Study ID Numbers: 01/2016/SLE/CurcuminvitaminD
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cameleia Diah Setyorini, Saiful Anwar Hospital:
SLE, vitamin D, SLEDAI, IL-6, TGF- β1

Additional relevant MeSH terms:
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Turmeric extract
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents