Investigation the effect of 25-hydroxy vitamin D3 (25OHD3) serum level on anxiety and depression in colorectal adenocarcinoma patients.
Design
A four arm parallel group non-randomised non-blinded before-after designed clinical trial without control group, 60 patients enrolled between march 2023 and march 2024.
Settings and conduct
In this trial 60 new cases referred to the Reza Radiotherapy Center will be included in based on criteria. Pearls of 5000 units of cholecalciferol of Zahravi Pharmaceutical Company are given based on the serum 25OHD3 level of intervention groups, meaured by enzyme-linked immunosorbent assay in
Central Jihad University Laboratory, according to the following instructions for 3 months: D: daily, I: every 5 days, B: every 7 days, S: every 10 days. Patients will fill out Zung's Self-rating anxiety Scale (S.A.S) and Zung's Self-rating depression Scale (S.D.S) questionnaires before and after the intervention, and their serum 25OHD3 will be measured monthly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-65 years old; Ability to write and read in Persian; Ability to answer questionnaire questions.Exclusion criteria: Complicated dibetes 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; Serum level of ionized calcium more than 5.6 mg/dL.
Intervention groups
Deficiency group (D): 25OHD3 serum level below 12 ng/ml; Insufficiency group (I): 25OHD3 serum level 12-20 ng/ml; Borderline group (B): 25OHD3 serum level 20-30 ng/ml; Sufficient group (S): 25OHD3 serum level above 30 ng/ml
Main outcome variables
Zung S.D.S score; Zung S.A.S score; 25OHD3 serum level before intervention; 25OHD3 serum level after the end of intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220609055113N1
Registration date:2022-09-04, 1401/06/13
Registration timing:prospective
Last update:2022-09-04, 1401/06/13
Update count:2
Registration date
2022-09-04, 1401/06/13
Registrant information
Name
Reyhaneh Entezari heravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3765 8488
Email address
r.entezari98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-08, 1401/12/17
Expected recruitment end date
2024-03-08, 1402/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of serum vitamin D levels on anxiety and depression in patients with colorectal adenocarcinoma
Public title
"Effect of vitamin D on anxiety and depresion of patients with colorectal cancer"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write in Persian
Ability to answer questionnaire questions
Exclusion criteria:
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
Serum level of ionized calcium more than 5.6 mg/dL
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Mashhad Medical Sciences Branch
Major depressive disorder, single episode, unspecified
Primary outcomes
1
Description
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
2
Description
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
3
Description
Serum level of 25-hydroxy vitamin D3
Timepoint
Before starting the intervention and 30, 60 and 90 days after starting cholecalciferol
Method of measurement
enzyme-linked immunosorbent assay
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: patients with a serum level of 25-hydroxyvitamin D3 less than 12 ng/ml receive a total of 85 pearls of 5000 units of cholecalciferol from Zahravi Pharmaceutical Company, one pearl per day for 3 months.
Category
Treatment - Drugs
2
Description
The second intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 12-20 ng/ml receive a total of 18 pearls of 5000 units of cholecalciferol from Zahravi Pharmaceutical Company, one pearl every 5 days for 3 months.
Category
Treatment - Drugs
3
Description
The third intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 20-30 ng/ml will receive a total of 14 pearls of 5000 units of cholecalciferol from Zahravi Pharmaceutical Company, one pearl every 7 days for 3 months.
Category
Treatment - Drugs
4
Description
The fourth intervention group: patients with a serum level of 25-hydroxyvitamin D3 above 30 ng/ml will receive a total of 11 pearls of 5000 units of cholecalciferol from Zahravi Pharmaceutical Company, one pearl every 10 days for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Reza Radiotherapy and Oncology Center
Full name of responsible person
Mahdieh Dayani
Street address
Reza Radiotherapy and Oncology Center, 19 Rafsanjani St., Haftom Azar Sq., Rafsanjani Hwy., International Fair Blvd., Mashhad, IRAN
City
Mashhad
Province
Razavi Khorasan
Postal code
9184166759
Phone
+98 51 3500 8000
Fax
+98 51 3522 5671
Email
Info@rroc.ir
Web page address
https://www.rroc.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vahid Pouresmaeil
Street address
Faculty of Medicine, Azad University of Mashhad,14th Imam Khomeini St., 14th Imam Khomeini St., Imam Khomeini Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9133735971
Phone
+98 51 3225 0041
Email
v.pouresmaeil@mshdiau.ac.ir
Web page address
https://mashdms.iau.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad university, Mashhad medical science branch, Dr. Mohammad shahinfar medical school
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Central Jihad University Laboratory
Full name of responsible person
Reyhaneh Entezari heravi
Street address
Razi Jihad Academic Medical Complex, West Razi St, Between Dah-e-dey and Imam khomeini Sq, Razi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137844955
Phone
+98 51 3854 0000
Email
info.complex@jdm.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?