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

NCT ID: NCT03155477

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-10
• Study Completion Date: 2017-03-13

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.

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.

Conditions

SLE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

"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)

Group Type: EXPERIMENTAL

"Cholecalciferol" and "C. Xanthorrhiza"

Intervention Type: DIETARY_SUPPLEMENT

Cholecalciferol are given 400 IU 3 times daily for 3 months C. Xanthorrhiza are given 200 mg 3 times daily for 3 months

"Cholecalciferol" and "placebo"

Subjects received cholecalciferol 3×400 IU and placebo 3×1 tablet for 3 months (group I, n=20).

Group Type: PLACEBO_COMPARATOR

"Cholecalciferol" and "placebo"

Intervention Type: DIETARY_SUPPLEMENT

Cholecalciferol are given 400 IU 3 times daily for 3 months Placebo are given 3 times daily for 3 months

Interventions

"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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Teorol 400 IU Novell Pharmaceutical Laboratories; Curcuma Soho Industries Pharmacy; Teorol 400 IU Novell Pharmaceutical Laboratories

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saiful Anwar Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cameleia Diah Setyorini

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Handono Kalim, Prof.

Role: PRINCIPAL_INVESTIGATOR

References

Handono K, Pratama MZ, Endharti AT, Kalim H. Treatment of low doses curcumin could modulate Th17/Treg balance specifically on CD4+ T cell cultures of systemic lupus erythematosus patients. Cent Eur J Immunol. 2015;40(4):461-9. doi: 10.5114/ceji.2015.56970. Epub 2016 Jan 15.

Reference Type: BACKGROUND

PMID: 26862311 (View on PubMed)

Singgih Wahono C, Diah Setyorini C, Kalim H, Nurdiana N, Handono K. Effect of Curcuma xanthorrhiza Supplementation on Systemic Lupus Erythematosus Patients with Hypovitamin D Which Were Given Vitamin D3 towards Disease Activity (SLEDAI), IL-6, and TGF-beta1 Serum. Int J Rheumatol. 2017;2017:7687053. doi: 10.1155/2017/7687053. Epub 2017 Dec 28.

Reference Type: DERIVED

PMID: 29445400 (View on PubMed)

Other Identifiers

01/2016/SLE/CurcuminvitaminD

Identifier Type: -

Identifier Source: org_study_id