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IRCT20180306038979N1 IRCT 2018-03-16 Ahvaz University of Medical Sciences Effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with colorectal cancer Effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with colorectal cancer 2018-05-22 anticipated 80 Complete https://irct.ir/trial/30066 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were allocated randomly and by using a random number table, into one of four groups. Vitamin D, omega-3, and placebo tablets were placed into identical containers, and a person who is not involved in study protocol created the randomization list. All investigators, and participants were blinded to the random assignments, Blinding description: For blinding, study leader who is not involved in study protocol created the randomization list assigning participants to the vitamin D, omega-3, 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. 3 Colorectal cancer. Intervention 1: Intervention 1: a 50000 IU vitamin D perl, weekly+ 2 omega-3 fatty acid capsules, daily. Intervention 2: Intervention group 2: a 50000 IU vitamin D perl, weekly+ 2 omega-3 fatty acid placebo, daily. Intervention 3: Intervention group 3: two omega-3 fatty acid capsules+ a vitamin D placebo, weekly. Intervention 4: Control group: a vitamin D placebo, weekly+ 2 omega-3 fatty acid placebo, daily. Yes - There is a plan to make this available What will be shared: Primary and secondary outcome measures of the participants. When: Starting 1 year after publication. To whom: People working in academic institutions Conditions: Using the data in literature review Where to obtain: Email addresses How to obtain: Request the data sending email. Comments:
public Dr. Fatemeh Haidari
Golestan Highway
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8253 haidari_f@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr. Mohammadreza Vafa
Hemat Express way
Tehran Iran (Islamic Republic of) 61357-15794 +98 21 8670 4734 vafa.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with stage ӀӀ or ӀӀӀ colorectal cancer if they have to begin chemotherapy; Aged 18 years or more; BMI range of 18.5-30 kg/m2; Serum 25(OH)D < 30 ng/ml; Not having autoimmune disease, diabetes, hypertension, renal, hepatic, parathyroid, and gastrointestinal disorders; No taking vitamin D and/or omeaga-3 supplements and other vitamin- mineral supplements or parenteral nutrition; Not taking laxative, anti-inflammatory and blood thinner medications; Absence of allergic to fish and fish products, and history of having other cancers. 18 years no limit Both Affecting by any acute disease during the study; Changing the drug regimen; refusing to continue the chemotherapy; Unwilling to continue the study; Patients who had less than 90% compliance with treatment. C18.9 Malignant neoplasm of colon, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention 1: a 50000 IU vitamin D perl, weekly+ 2 omega-3 fatty acid capsules, daily Intervention group 2: a 50000 IU vitamin D perl, weekly+ 2 omega-3 fatty acid placebo, daily Intervention group 3: two omega-3 fatty acid capsules+ a vitamin D placebo, weekly Control group: a vitamin D placebo, weekly+ 2 omega-3 fatty acid placebo, daily Serum level of TNF-α. Timepoint: Before and 8 weeks after intervention. Method of measurement: Serum TNF-α levels will be assessed by ELISA and Bender Med kit (Bender Med, Germany). Tumor marker CEA. Timepoint: Before and 8 weeks after intervention. Method of measurement: Tumor marker CEA will be assessed by ELISA and CanAg kit (CanAg, Italy). Ahvaz University of Medical Sciences Approved 2018-03-06 Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Highway, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)