Status:
COMPLETED
Vitamin D and Curcumin Piperine Attenuates Disease Activity and Cytokine Levels in Systemic Lupus Erythematosus Patients
Lead Sponsor:
Saiful Anwar Hospital
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with a relatively high mortality and morbidity rate, especially in developing countries such as Indonesia. In Indonesia, a p...
Detailed Description
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with a relatively high mortality and morbidity rate, especially in developing countries such as Indonesia. In Indonesia, a p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05430087
Start Date
March 1 2020
End Date
January 31 2022
Last Update
June 24 2022
Active Locations (1)
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1
Saiful Anwar General Hospital
Malang, East Java, Indonesia, 65112