Department of Nutrition, Faculty of medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
Trials. 2021 Apr 20;22(1):292. doi: 10.1186/s13063-021-05224-6.
Cystic fibrosis (CF) is a genetic disorder, which is caused by the CFTR protein defects. Along with CFTR dysfunction, inflammation plays a key role in the disease outcomes. Inflammation may develop due to the internal dysfunction of the CFTR protein or external factors. Curcumin affects the CFTR protein function primarily as a corrector and potentiator and secondary as an anti-inflammatory and antimicrobial agent. The present study aims to assess the impact of nano-curcumin on clinical and inflammatory markers in children with CF.
This prospective, double blind control trial will be conducted at the Akbar Children's Hospital in Mashhad, Iran. Children with CF will be enrolled based on the eligibility criteria. Placebo and curcumin with the maximum dose of 80 mg considering the body surface of the patients will be administrated for 3 months. The primary outcome is to evaluate inflammation based on serum interleukin-6, interleukin-10, and hs-CRP, stool calprotectin, and neutrophil count of nasopharyngeal swab. The secondary outcome involved clinical assessment via spirometry, anthropometrics, and quality of life. They will be assessed before and after 3 months.
Due to the multifarious effects of curcumin on CF disease, it could be proposed as a nutritional strategy in the treatment of cystic fibrosis.
Iranian Registry of Clinical Trials IRCT20200705048018N1 . Registered on July 10, 2020.
囊性纤维化（CF）是一种遗传性疾病，由 CFTR 蛋白缺陷引起。除 CFTR 功能障碍外，炎症在疾病结局中也起着关键作用。炎症可能是由于 CFTR 蛋白的内在功能障碍或外部因素引起的。姜黄素主要作为校正剂和增强剂，其次作为抗炎和抗菌剂，影响 CFTR 蛋白功能。本研究旨在评估纳米姜黄素对 CF 患儿临床和炎症标志物的影响。
这项前瞻性、双盲对照试验将在伊朗马什哈德的阿克巴尔儿童医院进行。将根据入选标准招募 CF 患儿。给予安慰剂和最大剂量 80mg 的姜黄素（考虑到患者的体表面积），治疗 3 个月。主要结局是评估血清白细胞介素-6、白细胞介素-10 和 hs-CRP、粪便钙卫蛋白和鼻咽拭子中性粒细胞计数的炎症情况。次要结局包括通过肺活量测定、人体测量学和生活质量进行临床评估。将在 3 个月前后进行评估。
由于姜黄素对 CF 疾病有多种影响，它可以作为治疗囊性纤维化的营养策略。
伊朗临床试验注册处 IRCT20200705048018N1。于 2020 年 7 月 10 日注册。
