]>
IRCT20220609055113N1 IRCT 2022-09-04 Islamic Azad University "Effect of vitamin D on anxiety and depresion of patients with colorectal cancer" Evaluation of the effect of serum vitamin D levels on anxiety and depression in patients with colorectal adenocarcinoma 2023-03-08 anticipated 45 Complete https://irct.ir/trial/65568 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. 2 Condition 1: Anxiety. Condition 2: Depression. Intervention 1: The first intervention group: patients with a serum level of 25-hydroxyvitamin D3 less than 12 ng/ml receive 8 pearls of 50000 units of cholecalciferol from Zahravi Pharmaceutical Company one pearl weekly for 8 week and then 30 Tabs of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, daily for 24 days. Intervention 2: The second intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 12-20 ng/ml receive a total of 90 Tabs of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, one pearl daily for 90 days. Intervention 3: The third intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 20-30 ng/ml will receive a total of 60 pearls of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company accoriding to following command: Two days one pearl daily and then one day off for 3 months. Intervention 4: The fourth intervention group: patients with a serum level of 25-hydroxyvitamin D3 above 30 ng/ml will receive a total of 30 pearls of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, one pearl every 3 days for 3 months. Yes - There is a plan to make this available What will be shared: Only part of the data can be shared, such as information about the main outcome or the like. When: The access period starts 6 months after the results are published. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: Based on the criteria of the Ministry of Health, Treatment and Medical Education about clinical trial studies. Where to obtain: E-mail: r.entezari.iaum@gmail.com How to obtain: After obtaining permission from the supervisor, the information will be sent by email. Comments:
public Reyhaneh Entezari heravi
Unit 181, resalat, 7th ALLEY ,No. 3, Faramarz abbasi Ave, Faramarz abbasi Blvd, mashhad city
Mashhad Iran (Islamic Republic of) 9196111111 +98 51 3765 8488 r.entezari98@gmail.com Islamic Azad University scientific Reyhaneh Entezari heravi
Unit 181, resalat, 7th ALLEY ,No. 3, Faramarz abbasi Ave, Faramarz abbasi Blvd, mashhad city
Mashhad Iran (Islamic Republic of) 9196111111 +98 51 3765 8488 r.entezari98@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Ability to read and write in Persian Ability to answer questionnaire questions 18 years 70 years Both Complicated diabetes or hypertension History of visiting a psychiatrist or psychologist in the last 6 months or taking psychotropic drugs in the last 6 months Pregnancy Breastfeeding Taking vitamin D or vitamin D3 analogs in the last 3 months Vitamin D serum level more than 100 ng/ml F41.9 F32.9 Anxiety disorder, unspecified Major depressive disorder, single episode, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group: patients with a serum level of 25-hydroxyvitamin D3 less than 12 ng/ml receive 8 pearls of 50000 units of cholecalciferol from Zahravi Pharmaceutical Company one pearl weekly for 8 week and then 30 Tabs of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, daily for 24 days. The second intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 12-20 ng/ml receive a total of 90 Tabs of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, one pearl daily for 90 days. The third intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 20-30 ng/ml will receive a total of 60 pearls of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company accoriding to following command: Two days one pearl daily and then one day off for 3 months. The fourth intervention group: patients with a serum level of 25-hydroxyvitamin D3 above 30 ng/ml will receive a total of 30 pearls of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, one pearl every 3 days for 3 months. Depression score in Zung questionnaire. Timepoint: Before starting intervention, 90 days after starting to take cholecalciferol. Method of measurement: Zung Self-Rating Depression Scale questionnaire. Anxiety score in Zung questionnaire. Timepoint: Before starting intervention, 90 days after starting to take cholecalciferol. Method of measurement: Zung Self-Rating Depression Scale qestionnaire. Serum level of 25-hydroxy vitamin D3. Timepoint: Before starting the intervention and 90 days after starting cholecalciferol. Method of measurement: enzyme-linked immunosorbent assay. Zahravi Pharmaceutical Company Reza Radiotherapy and Oncology Center Omid parsina damavand pharmaceuitical company Islamic Azad university, Mashhad medical science branch, Dr. Mohammad shahinfar medical school Zahravi Pharmaceutical Company Reza Radiotherapy and Oncology Center Omid parsina damavand pharmaceuitical company Approved 2022-08-15 Ethics committee of Islamic Azad University of Mashhad Medical Sciences Branch NO. 181 , Resalat 7., Faramarz Abbasi 3., Faramarz Abbasi blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)