Randomised Clinical Trial Study: The Combination of Vitamin D and Curcumin Piperine Attenuates Disease Activity and Pro-inflammatory Cytokines Levels Insystemic Lupus Erythematosus Patients

Background Curcumin-piperine might synergise with vitamin D to induce clinical remission in patients with systemic lupus erythematosus (SLE). Objective To observe the improvement of patients with SLE clinically and the levels of inflammatory cytokines after receiving supplements of curcumin-piperine and cholecalciferol (Vitamin D3). Methods Forty-five female SLE patients were included in a three-month double-blind, randomized controlled trial. Participants were classified into: Group I (400 IU cholecalciferol + placebo three times daily, n = 15), Group II (600 mg curcumin + 15,800 m piperine once daily and three times daily placebo, n = 15), and Group III (cholecalciferol 400 IU three times and 600 mg curcumin + 15,800 mg piperine once a day, n = 15). Mexican SLE disease activity score (Mex-SLEDAI), fatigue severity scale (FSS), TGF-beta, and IL-6 levels were measured from all patients before and after the treatments. Results Mex-SLEDAI, FSS, and IL-6 were reduced significantly, while TGF-beta serum levels were increased in all groups after the treatments (p <0.05). Changes in Mex-SLEDAI score (p = 0.003 and p = 0.008), FSS (p = 0.001 and p <0.001), and TGF-beta (p = 0.003 and p = 0.004) serum levels were significantly higher in group III compared to the group I or group II. On the other hand, changes in Mex-SLEDAI, FSS, IL-6, and TGF-beta serum levels were similar between groups I and II. Conclusion Although vitamin D or curcumin-piperine alone could improve the clinical outcome and cytokines levels in SLE, curcumin-piperine combined with vitamin D had the best outcome in improving the disease activity and cytokines levels among patients with SLE. (ClinicalTrials.gov number, NCT05430087).