The effects of nano-curcumin as a nutritional strategy on clinical and inflammatory factors in children with cystic fibrosis: the study protocol for a randomized controlled trial

Abstract

Background 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. Methods 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. Discussion Due to the multifarious effects of curcumin on CF disease, it could be proposed as a nutritional strategy in the treatment of cystic fibrosis. Trial registration Iranian Registry of Clinical Trials IRCT20200705048018N1. Registered on July 10, 2020.

Effectiveness of Curcumin on Outcomes of Hospitalized COVID-19 Patients: A Systematic Review of Clinical Trials

“…Curcuminoids have received approval from the USA Food and Drug Administration (FDA), and these compounds have good tolerability and safety [26]. Furthermore, they have already been tested with some successes in clinical trials targeting various diseases [27][28][29][30].…”

Curcumin supplementation in pediatric patients: A systematic review of current clinical evidence

“…Nano‐curcumin is dosed according to body surface area ( × 80 mg) once daily for 3 months. This study aimed to evaluate the inflammatory state (based on the values of serum Il‐6, IL‐10, and hs‐CRP, stool calprotectin, and neutrophil count of nasopharyngeal swabs) and clinical condition of CF patients (by spirometry, anthropometrics and quality of life) before and after 3 months of curcumin or placebo (Talebi et al, 2021).…”

“…Additionally, curcumin stimulates CFTR channel activity of both wild type and mutated types (ΔF508‐CFTR and G551D‐CFTR) in a dose‐dependent manner by prolongation of the mean open times (Berger et al, 2005; Cartiera et al, 2010; Zhang, Chen, Wang, Peng, & Cai, 2014). CF patients may also benefit from the antibacterial, antiinflammatory, and antioxidant activities of curcumin (Chaudhary et al, 2019; Karaman, Fırıncı, Arıkan Ayyıldız, & Bahar, 2013; Lee et al, 2010; Talebi et al, 2021). Moreover, a recent systematic review and meta‐analysis found that curcumin improves health‐related quality of life in the adult population (Sadeghian, Rahmani, Jamialahmadi, Johnston, & Sahebkar, 2021).…”

“…Cai, 2014). CF patients may also benefit from the antibacterial, antiinflammatory, and antioxidant activities of curcumin (Chaudhary et al, 2019;Karaman, Fırıncı, Arıkan Ayyıldız, & Bahar, 2013;Lee et al, 2010;Talebi et al, 2021). Moreover, a recent systematic review and meta-analysis found that curcumin improves health-related quality of life in the adult population (Sadeghian, Rahmani, Jamialahmadi, Johnston, & Sahebkar, 2021).…”

“…Nano-curcumin is dosed according to body surface area ( ) once daily for 3 months. This study aimed to evaluate the inflammatory state (based on the values of serum Il-6, IL-10, and hs-CRP, stool calprotectin, and neutrophil count of nasopharyngeal swabs) and clinical condition of CF patients (by spirometry, anthropometrics and quality of life) before and after 3 months of curcumin or placebo(Talebi et al, 2021).Rafeey and co-workers assessed the effect of curcumin supplementation on anthropometrics and quality of life among children with CF. Forty CF patients (aged 5-18 years) were recruited and randomly assigned to receive nano-curcumin (240 mg daily) or placebo for 6 months.…”