Vitamin D and Curcumin Piperine Attenuates Disease Activity and Cytokine Levels in Systemic Lupus Erythematosus Patients

Plain-language summary

This study evaluates the effect of Vitamin D3 (Cholecalciferol) and Curcumin-Piperine supplementation on disease activity and inflammatory (cytokine) levels in patients with systemic lupus erythematosus. It included SLE patients with active disease and low vitamin D levels. The study was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Saiful Anwar Hospital

Intervention

Observe the clinical outcome and inflammatory cytokines levels in patients with systemic lupus erythematosus (SLE) after being supplemented with Cholecalciferol (Vitamin D3) and Curcumin-Piperine.

Start date

3/1/2020

Estimated completion

1/31/2022

Countries

Indonesia

Related genes

Locations

• Malang, Indonesia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* SLE patients referred to the Rheumatology outpatient clinic Saiful Anwar General Hospital, Malang, Indonesia
* Had an active disease, characterized by the Mexican SLE Disease Activity Index (Mex-SLEDAI) score \>3
* Had low vitamin D levels (serum vitamin D3 levels \<30 ng/ml)

Exclusion Criteria:

* Pregnant or breast-feeding patients
* Took supplementations containing vitamin D or curcumin in the last three months
* Had severe liver disorders (AST or ALT levels \>2.5 times of upper normal limit)
* Had impaired renal function (GFR \< 25 ml/min or oliguria with urine output \< 400 ml/day)
* Had other autoimmune diseases or severe infections such as tuberculosis, pneumonia, or HIV, history of renal stones, hypercalciuria, intestinal malabsorption
* Refusal to participate in the study