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Kidney transplant recipients (KTRs) are at high risk of vascular dysfunction and delayed graft function. The current study presents a protocol for an interventional clinical trial to survey the hypothesis, that curcumin-piperine co-supplementation is effective in improving kidney allograft function and can reduce inflammation and vascular complication in KTR.
The study is randomized, double-blind, and placebo-controlled, with two parallel arms that will include a total of forty KTRs. KTRs aged 18-60 years will be randomized in a ratio of 1:1 to receive either curcumin-piperine (500 mg curcumin and 5 mg piperine) or a matching placebo (505 mg maltodextrin) for 12 weeks immediately after kidney transplantation (time 0) and week 12. The primary outcome is to evaluate the immediate, delayed, and slow graft function, serum creatinine, and eGFR. The secondary outcomes are glycemic control, lipid profile, length of hospital day, duration of DGF, number and dosage of immunosuppressive drugs, and inflammation.
This study is the first randomized clinical trial based on our knowledge to assess the effect of curcumin-piperine co-supplementation on kidney allograft function in KTRs. Curcumin supplementation may be effective in increasing graft function by reducing inflammation and oxidative stress.
Trial registration: This trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with code “IRCT20110123005670N29”, https://en.irct.ir/trial/63535. The registration date is June 22, 2022.