The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial

Determining the effect of curcumin and vitamin D supplementation on inflammatory biomarkers and nutritional status of patients with colorectal cancer

A randomized, double-blind, parallel-group, controlled clinical trial on 92 patients with colorectal cancer. Randomization was performed using random allocation software with a block size of 4 and a ratio of 1:1:1:1.

Patients with colorectal cancer referred to Amir Hospital, Mehr Clinic, Pardis Clinic, Hazrat Abolfazl Chemotherapy Center, and Motahari Clinic will be included in the study through convenience sampling method upon informed consent, according to the inclusion criteria and the absence of exclusion criteria. Blinding: The appearance, packaging, color, and size of the supplements and the dosage will be similar. At the beginning and end of the study, inflammatory factors, hand muscle strength, quality of life questionnaire, body composition analysis, and dietary components will be measured.

Inclusion criteria: Colorectal cancer patients At least 3-month life expectancy Using chemotherapy method Nonallergic to turmeric Exclusion criteria: Unwillingness to participate in the study Not continuing chemotherapy

Curcumin group: 80 mg of nanocurcumin daily and one placebo vitamin D tablet per week; Vitamin D group: one tablet of vitamin D (50,000) per week and two placebo nanocurcumin tablets per week; Curcumin and vitamin D group: 80 mg of nanocurcumin daily and one tablet of vitamin D (50,000) per week; Placebo group: Two tablets of curcumin daily and one placebo vitamin D tablet per week.

Interleukin 6, tumor necrosis factor alpha, C-reactive protein to albumin ratio, quality of life, body fat, lean body mass, body mass index, hand muscle strength, basal metabolism, dietary components

The expected start date of participant recruitment was inadvertently entered in the IRCT registration form as approximately three months earlier than the actual date of trial registration. However, participant recruitment did not begin until after the trial had been registered with IRCT. This discrepancy has caused difficulties in submitting manuscripts arising from this trial, as journals have interpreted the study as a retrospectively registered clinical trial. We would therefore kindly request that the expected start date of participant recruitment be amended from 1403/12/10 to 1404/03/01 and the expected end date from 1405/01/31 to 1405/03/01 to accurately reflect the intended recruitment period

Using random allocation software with a block size of 4 and a ratio of 1:1:1:1, the groups assigned to each participant will be labeled as A, B, C, D in identical sealed envelopes by an outsider.

The appearance, packaging, color, and size of the supplements and placebos will be similar. The supplements and placebos will be labeled by an outsider in line with the names of the groups with letters A, B, C, and D. Therefore, both the participants and the researcher will be unaware of the study groups and the use of the drug and placebo until the end of the study.