Evaluation of the effect of vitamin D on anxiety and depression in patients with
esophageal cancer
Design
A 4-arm clinicaltrial with parallel groups without randomization
No blinding with before and after design, without control group on 30 patients
will be done
Settings and conduct
In this study ,30 new cases of esophageal cancerwere referred
They will be admitted to the Reza Radiotherapy Center based on the criteria .Pearls of 5000 units of cholecalciferol of Zahravai pharmaceutical company
according to the amount of serum 25OHD3 of the intervention groups according to the instructions
It is given below: deficiency group :daily ,deficiency :every 5 days ,borderline :every 7Day ,sufficient :every 10 days .Serum level of 25OHD3 in the central laboratory University of Mashhad Jahad on enzyme-linked adsorbent immunoassay method will be measured .Patients before and after the intervention questionnaires Anxiety and depression fill Zong and 25hydroxyvitamin D3 Their serum is measured monthly.
Participants/Inclusion and exclusion criteria
Inclusion :At least 6 months passed since the diagnosis of esophageal cancer.Above 18 y .Ability to read and write .ability to answer questionnaire .ability to swallow oral medication
Exclusion :Previous psychiatric history .Taking psychiatric drugs in the last 6 months .History of drugabuse before cancer .Pregnancy or intention to pregnancy .Breastfeeding .Taking vitD in the last 3months .Occurrence of any major stressful event after the start of the study
Intervention groups
Administration of 50000U of vitamin D pearls weekly at a serum level below12ng/ml ,every 10days at a serum level of 12-20 ,every 14days at a serum level of 20-30 ,monthly at a serum level above 30
Main outcome variables
Zung anxiety test before and after study
Zung depression test before and after study
Serum level of 25 hydroxyvitamin D before and after study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220731055593N1
Registration date:2023-01-07, 1401/10/17
Registration timing:prospective
Last update:2023-01-07, 1401/10/17
Update count:0
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Masume Esmaeil Pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 205 4542
Email address
masumesp@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-05-19, 1402/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin D on anxiety and depression in patients with esophageal cancer
Public title
The effect of vitamin D on anxiety and depression in patients with esophageal cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Esophageal cancer diagnosed at least 6 months ago
Age above 18years
Ability to read and write
Ability to swallow oral medication
Exclusion criteria:
Pregnancy
Breastfeeding
Past psychological history
History of drug abuse before cancer
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Mashhad Islamic Azad University
Street address
Shahid Chamran Ave.Chamran15
City
Mashhad
Province
Razavi Khorasan
Postal code
9137635567
Approval date
2022-06-29, 1401/04/08
Ethics committee reference number
IR.IAU.MSHD.REC.1401.058
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Serum vitamin d3
Timepoint
Before - 3weeks after
Method of measurement
Serum vitamin d3
2
Description
Depression
Timepoint
Before-after
Method of measurement
Zung questionnaire
3
Description
Anxiety
Timepoint
Before-after
Method of measurement
Zung questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group:Weekly prescription of vitamin D 50,000 units
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Reza Radiotherapy & Oncology Center
Full name of responsible person
Masume Esmaeil Pour Toroghi
Street address
Northern khayam 46.,shokri Blvd.,4th shokri.
City
Mashhad
Province
Razavi Khorasan
Postal code
9196747386
Phone
+98 915 205 4542
Email
masumesp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tooraj Zandbaf
Street address
Bazarche Sarab, No.Imam Khomeini 14.,Dr.Shahinfar Medical Faculty Islamic Azad University Of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 915 511 4523
Email
tooraj.zandbaf@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoume Esmaeil Pour Toroghi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Northern khayam 46.,shokri Blvd.,4th shokri.
City
Mashhad
Province
Razavi Khorasan
Postal code
9196747386
Phone
+98 915 205 4542
Email
masumesp@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masume Esmaeil Pour Toroghi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Northern khayam 46.,shokri Blvd.,4th shokri.
City
Mashhad
Province
Razavi Khorasan
Postal code
9196747386
Phone
+98 915 205 4542
Email
masumesp@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masume Esmaeil Pour
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Khayam Ave 46, shokri Blvd 4, Khayam apartment
City
Mashhad
Province
Razavi Khorasan
Postal code
9196747386
Phone
+98 915 205 4542
Email
masumesp@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The original information cannot be shared, but the coded data is in the possession of the responsible Masume Esmaeil Pour.
When the data will become available and for how long
The access period starts 12months after the results are published
To whom data/document is available
Academic institutions and researchers
Under which criteria data/document could be used
Medical students
From where data/document is obtainable
The information and data are at the disposal of Masume Esmaeil Pour, the person responsible of the project, and you can contact the following email address:
masumesp@yahoo.com
What processes are involved for a request to access data/document
After conducting the intervention and reviewing the data and results of the research, almost 1 year after the publication of the results, the data are accessible