]>
IRCT20250110064340N1 IRCT 2025-03-27 Shiraz University of Medical Sciences The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial RCT The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial 2025-05-21 anticipated 92 Complete https://irct.ir/trial/82122 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The intervention will last for 8 weeks. The study participants will be divided into four groups:1- Curcumin group; 2- Vitamin D group; 3- Curcumin and vitamin D group; 4- Placebo group, Randomization description: 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, Blinding description: 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. 1 colorectal cancer. Intervention 1: First intervention group: Curcumin group: They will receive 2 capsules of 40 mg of nano-curcumin daily (80 mg daily) and one vitamin D placebo weekly for 8 weeks. Manufacturer: Exir Nano Sina Company-Tehran. Intervention 2: Second intervention group: Vitamin D group: They will receive one vitamin D tablet (50000IU) per week and 2 nanocurcumin placebo capsules per day. Manufacturer: Zahravi Company-Tabriz. Intervention 3: The third intervention group (Curcumin + Vitamin D group): Two capsules of 40 mg of nano-curcumin daily (80 mg daily) and one tablet of vitamin D (500,000 IU) weekly for 8 weeks. Intervention 4: Control group: This group will receive two capsules of the nanocurcumin placebo daily and one capsule of the vitamin D placebo weekly for 8 weeks. The vitamin D placebo contains food grade paraffin, which is similar in shape and color to a vitamin D tablet. Manufacturer: Zahravi Company, Tabriz The curcumin placebo contains lecithin and food grade yellow dye E104, which is similar in shape and color to a curcumin tablet. Manufacturer: Exir Nano Sina Company, Tehran. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available.
public Marzieh Zamani
School of Nutrition and Food Sciences, Opposite Bargh Sports club, Razi Blvd
shiraz Iran (Islamic Republic of) 7156675500 +98 71 3725 1001 mzamani.dmm@gmail.com Shiraz University of Medical Sciences scientific Seyed Jalil Masoumi
School of Nutrition and Food Sciences, Opposite Bargh Sports Club, Razi Blvd
shiraz Iran (Islamic Republic of) 7153675500 +98 71 3725 1001 scnutrition@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with colorectal cancer 18-60 years of age At least 3 months of life expectancy Using chemotherapy BMI=18-30 kg/m2 Nonallergic to turmeric Not suffering from hypertension or renal, hepatic, or parathyroid disorders 18 years 60 years Both Unwillingness to participate in the study Not continuing chemotherapy Fever greater than 38.5°C in three days before receiving the first dose of the supplementary drugs Known positive HIV serology Patients with other malignancies, Pregnancy and lactation C18.9 Malignant neoplasm of colon Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo First intervention group: Curcumin group: They will receive 2 capsules of 40 mg of nano-curcumin daily (80 mg daily) and one vitamin D placebo weekly for 8 weeks. Manufacturer: Exir Nano Sina Company-Tehran Second intervention group: Vitamin D group: They will receive one vitamin D tablet (50000IU) per week and 2 nanocurcumin placebo capsules per day. Manufacturer: Zahravi Company-Tabriz The third intervention group (Curcumin + Vitamin D group): Two capsules of 40 mg of nano-curcumin daily (80 mg daily) and one tablet of vitamin D (500,000 IU) weekly for 8 weeks Control group: This group will receive two capsules of the nanocurcumin placebo daily and one capsule of the vitamin D placebo weekly for 8 weeks. The vitamin D placebo contains food grade paraffin, which is similar in shape and color to a vitamin D tablet. Manufacturer: Zahravi Company, Tabriz The curcumin placebo contains lecithin and food grade yellow dye E104, which is similar in shape and color to a curcumin tablet. Manufacturer: Exir Nano Sina Company, Tehran Tumor necrosis factor alpha. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D. Method of measurement: Using laboratory kit and ELISA method. Interleukin 6. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D. Method of measurement: Using laboratory kit and ELISA method. C-reactive protein to albumin ratio. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D. Method of measurement: Using a laboratory kit. Hand muscle strength. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D. Method of measurement: Using handgrip. Quality of life. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D. Method of measurement: Quality of life questionnaire. Body mass index, basal metabolic rate, fat mass, fat-free mass, weight. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D. Method of measurement: Using BIA. Dietary components include energy, carbohydrates, protein, fat, and fiber. Timepoint: At the beginning of the study (before the intervention), 4 weeks after taking curcumin and vitamin D and 8 weeks after taking curcumin and vitamin D. Method of measurement: Using a 24-hour food recall questionnaire. Shiraz University of Medical Sciences Approved 2024-10-13 Ethics Committee of Shiraz University of Medical Sciencesal Science Shiraz University of Medical Sciences, Zand Blvd shiraz Fars Iran (Islamic Republic of)