Comparison of coenzyme Q10 efficacy on some of inflammatory factors and oxidative stress status, disease activity index and quality of life in patients with ulcerative colitis

1- Determination and comparison of the effects of coenzyme Q10 and placebo on the serum concentration of inflammatory factors (IL-10 and IL-17) in patients with ulcerative colitis. 2- Determination and comparison of the effects of coenzyme Q10 and placebo on the activity of NF-kB and Nrf2 in patients with ulcerative colitis. 3- Determination and comparison of co-enzyme Q10 and placebo effects on serum concentration of AMPs (hBD2 and cathelicidin LL-37) in patients with ulcerative colitis 4. Determination and comparison of coenzyme Q10 and placebo effect on microRNA-146a expression in patients with ulcerative colitis. 5- Determination and comparison of coenzyme Q10 and placebo on the quality of life in patients with ulcerative colitis.

The current study is designed s a randomized clinical trial.In this research, 50 eligible patients referring to Colorectal Research Center of Rasoul-e-Akram Hospital, Tehranwere chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.

This study was designed to determine the effect of coenzyme Q10 supplementation on serum inflammatory factors and oxidative stress, antimicrobial peptides, microRNA-146a expression and quality of life in ulcerative colitis patients as a double blinded randomized clinical trial. This study is performed on 100 patients with ulcerative colitis referring to Rasoul-e-Akram Hospital in Tehran. Studied participants are randomly divided to two groups of intervention and control which consuming 2 coenzyme Q10 capsules per day and 2 placebo capsules containing rice flour for 8 weeks, respectively. In order to performing the double-blinded of study, before study beginning, the canisters containing CoQ10 capsule can be provided by someone other than the researcher, and the placebo capsules in appearance are similar to the CoQ10 capsules and the researcher are not be aware about the allocation of studied subjects in each group during the evaluation of the studied outcomes until the end of the intervention period.

The inclusion criteria of study are: age 18 and above, BMI greater than 18.5 and less than 30, and each of the two sexes. Also, the non-criteria of study include: changing the type and dosage of the drug over the past month, the incidence of other autoimmune diseases, cancer, pregnancy or lactation in women, the use of multi vitamin-mineral supplements, antioxidants, and also the use of anticoagulants, blood cholesterol lowering drugs, anti-TNF drugs, and glucocorticosteroids over the past month.

In current study, from 100 patients with ulcerative colitis, 50 patients in the intervention group will receive two daily capsules containing 100 mg of pure coenzyme Q10 (Health Burst, USA) after meal for 8 weeks. While, 50 patients in the control group will use two daily placebo capsules containing rice flour for 8 weeks.

IL-10 ;IL-17; NF-kB; hBD2; Nrf2; cathelicidin LL-37; microRNA-146a; Quality of Life

For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 100 subjects, 25 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will enter based on the sequence produced into study and the drug packets with code registered will allocate to the individual. Therefore, before participants selection, they will be unaware of the type of intervention that will receive, as well as a random sequence produced during the study will be immune from prediction.

In order to performing the double-blinded of study, before study beginning, the canisters containing CoQ10 capsule can be provided by someone other than the researcher, and the placebo capsules in appearance are similar to the CoQ10 capsules and the researcher are not be aware about the allocation of studied subjects in each group during the evaluation of the studied outcomes until the end of the intervention period.

Only a section of the data, such as primary outcomes information or the like, will be shared.

ََAccess period start 6 months after results publishing.

The obtained data from current study will be available only for working researchers in academic and scientific institutions.

Six months after the publicated papers from this study, the obtained data will be available to the researchers for further analysis.

Applicants can be communicated to correspond author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran university of Medical Sciences, Hemat Express way, Tehran Cell phone:+98 21 8670 4743 Email:vafa.m@iums.ac

Applicants will be given access to the obtained data from current study by sending an email to the correspond author.