Effect of vitamin D, omega 3 fatty acids supplementation and co-supplementation of them on liver, inflammatory biomarkers, and oxidative stress in patients with colorectal cancer

Evaluation of the effect of vitamin D, omega 3 fatty acids supplementation and co-supplementation of them on liver, inflammatory biomarkers, and oxidative stress in patients with colorectal cancer

The study is done in Phase 3 clinical trials with a control group, in a factorial design, double-blind and randomized allocation. 80 eligible colorectal cancer patients were randomly allocated into 4 groups (vitamin D, omega-3, co-supplementation, placebo). For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks.

The participants, in Oncology clinic of Tehran Gastroenterology & Hepatology Center, who meet the criteria, will be randomly allocated into 4 groups. Blood samples were taken to quantify serum levels of 25(OH)D, and liver enzymes at baseline and after 8 weeks of intervention.

Inclusion criteria: Patients with stage ӀӀ or ӀӀӀ colorectal cancer and were candidate to receive chemotherapy; Aged 18 years or more; BMI range of 18.5-30 kg/m2; Serum 25(OH)D < 30 ng/ml; Not having autoimmune or chronic diseases; No taking vitamin D and/or omeaga-3 supplements and other vitamin- mineral supplements; Not taking laxative and anti-inflammatory medications; Not allergic to fish and fish products.

The intervention groups, for an 8-week period, will be randomly allocated into 4 groups: 1) a 50000 IU vitamin D tablet (Zahravi, Iran), weekly+ 2 omega-3 fatty acid capsules (each capsule containing 330 mg omeg-3 fatty acid), daily (Minami Nutrition, Belgium); 2) a 50000 IU vitamin D tablet, weekly+ 2 omega-3 fatty acid placebo (Zahravi, Iran), daily; 3) a vitamin D placebo (Zahravi, Iran), weekly+ 2 omega-3 fatty acid capsules; 4) a vitamin D placebo, weekly+ 2 omega-3 fatty acid placebo, daily.

Serum level of TNF-α

For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 80 subjects, 20 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.

For blinding, a person who is not involved in study protocol created the randomization list assigning participants to the vitamin D, omega-3, co-supplementation or the placebo group. Vitamin D, omega-3, and placebo tablets are placed into unlabeled identical containers. The study leader will label these containers with participant numbers using the randomization list. All investigators, and participants were blinded to the random assignments.

A part of the data will be shared, such as primary outcomes.

4 months after the publication of the results.

researchers and students of university.

Four months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis.

Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com

Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com