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CompletedNCT03155477Updated May 17, 2017

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

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

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jun 2016, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • SLE

Keywords

  • SLE, vitamin D, SLEDAI, IL-6, TGF- β1
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In context

Lupus Erythematosus, Systemic

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.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Saiful Anwar Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
39 participants (actual)

Study arms

  • 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"

  • 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"

Interventions

  • 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

    Also known as: Teorol 400 IU Novell Pharmaceutical Laboratories, Curcuma Soho Industries Pharmacy

  • 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

    Also known as: Teorol 400 IU Novell Pharmaceutical Laboratories

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What researchers measure

Primary outcomes

  1. SLE disease activity

    SLE disease activity was assessed using SLEDAI in the last 10 days

    Time frame: 3 months

Secondary outcomes

  1. IL-6

    IL-6 serum level (pg/ml)

    Time frame: 3 months

  2. TGF-β1

    TGF-β1 serum level (pg/ml)

    Time frame: 3 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 26862311 ↗
  • 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. PubMed 29445400 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2017
First posted
May 16, 2017
StartActual
Jun 10, 2016
Primary completionActual
Mar 13, 2017
CompletionActual
Mar 13, 2017
Last update
May 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03155477
Lead sponsor
Saiful Anwar Hospital
Responsible party
Cameleia Diah Setyorini (Medical Doctor, Saiful Anwar Hospital) — Principal investigator
First posted
May 16, 2017
Start date
Jun 10, 2016
Primary completion
Mar 13, 2017
Completion
Mar 13, 2017
Last update
May 17, 2017

Study contacts

Handono Kalim, Prof.
principal investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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