NCT03155477

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

May 13, 2017

Last Update Submit

May 15, 2017

Conditions

SLE

Keywords

SLE, vitamin D, SLEDAI, IL-6, TGF- β1

Outcome Measures

Primary Outcomes (1)

  • SLE disease activity

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

    3 months

Secondary Outcomes (2)

  • IL-6

    3 months

  • TGF-β1

    3 months

Study Arms (2)

"Cholecalciferol" and "C. Xanthorrhiza"

EXPERIMENTAL

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" and "placebo"

PLACEBO COMPARATOR

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

Dietary Supplement: "Cholecalciferol" and "placebo"

Interventions

"Cholecalciferol" and "C. Xanthorrhiza"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

Also known as: Teorol 400 IU Novell Pharmaceutical Laboratories, Curcuma Soho Industries Pharmacy
"Cholecalciferol" and "C. Xanthorrhiza"
"Cholecalciferol" and "placebo"DIETARY_SUPPLEMENT

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
"Cholecalciferol" and "placebo"

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26862311BACKGROUND

  • 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.

    PMID: 29445400DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Handono Kalim, Prof.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 13, 2017

First Posted

May 16, 2017

Study Start

June 10, 2016

Primary Completion

March 13, 2017

Study Completion

March 13, 2017

Last Updated

May 17, 2017

Record last verified: 2017-05