The effect of supplementation on reducing depression in children with cancer
Design
Non-randomized clinical trial assigned to intervention and control groups. with 75 samples
Settings and conduct
In children with malignancy who are on the verge of depression or depression according to the CDI test, they are treated with zinc by measuring zinc levels. In the group of patients with zinc deficiency, in addition to the standard treatment for depression, they are treated orally with 10 mg of zinc gluconate daily.In the group with normal zinc levels, the first group of patients with normal zinc levels receive 10 mg of zinc gluconate daily.
In the second group, patients with normal zinc levels also receive only depression treatment. One month later, all three groups are tested for CDI. The project will be carried out in Bu Ali Hospital
Participants/Inclusion and exclusion criteria
Age between 7 and 18 years, suffering from chemotherapy-treated malignancy, not more than one month after the last dose of chemotherapy, not taking antidepressants of any category during the past month, not taking zinc supplements or other supplements Contains zinc compounds during the past month, consent to fill out a questionnaire, regular use of antidepressants or zinc
Intervention groups
Intervention group: In addition to the standard treatment for depression, the group of patients with zinc deficiency will receive oral treatment with 10 mg of zinc gluconate daily at the discretion of thIntervention group: Group with normal zinc level The first group of patients in normal zinc level receive 10 mg of zinc gluconate dailye child psychiatrist.
Control group: The second group of patients with normal zinc levels also receive only depression treatment and do not receive zinc supplements
Main outcome variables
Depression score based on CDI tes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190202042583N1
Registration date:2020-08-14, 1399/05/24
Registration timing:registered_while_recruiting
Last update:2020-08-14, 1399/05/24
Update count:0
Registration date
2020-08-14, 1399/05/24
Registrant information
Name
Mohammad Naderisorki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 7837
Email address
dr.naderisorki@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-22, 1398/01/02
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation on reducing depression in children with cancer referred to the oncology ward of Bu Ali Sina Hospital in Sari
Public title
The effect of supplementation on reducing depression in children with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 7 to 18 years
Having malignancy treated with chemotherapy
Not more than one month has passed since the last round of chemotherapy
Do not take antidepressants of any category during the past month
Do not take zinc supplements or other supplements containing zinc compounds during the past month
Satisfaction to test the serum level by taking a blood sample
Regular use of antidepressants or zinc supplements
Exclusion criteria:
Congenital diseases of zinc metabolism such as acrodermatitis enteropathy, chronic inflammatory bowel disease, malabsorption syndromes
Age
From 7 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Not randomized
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
committee of Mazandaran University of Medical Sciences.
Street address
Central Headquarters of Mazandaran University of Medical Sciences,at the beginning of Valiasr Highway,Joibar Three Ways,Imam Square, Sari
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.MAZUMS.REC.1398.1182
Health conditions studied
1
Description of health condition studied
Depression in pediatric patients with malignancy
ICD-10 code
F06.3
ICD-10 code description
Mood disorder due to known physiological condition
Primary outcomes
1
Description
Depression score based on the Mariaquas Children Depression Inventory "CDI"
Timepoint
day 30
Method of measurement
CDI test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the standard treatment for depression, the group of patients with zinc deficiency will receive oral treatment with 10 mg of zinc gluconate daily at the discretion of the child psychiatrist.
Category
Treatment - Drugs
2
Description
Intervention group: Group with normal zinc level The first group of patients in normal zinc level receive 10 mg of zinc gluconate daily
Category
Treatment - Drugs
3
Description
Control group: The second group of patients with normal zinc levels also receive only depression treatment and do not receive zinc supplements
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Sina Hospital in Sari
Full name of responsible person
Mohamad Naderi Soraki
Street address
Sari. The beginning of Ghaem Shahr road. Bu Ali Sina Hospital
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱۴۸۱۵۷
Phone
+98 11 3304 4001
Email
publicrel@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
ساری.میدان معلم. طبقه پایین دارو خانه 13 آبان
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohmmad Naderi Soraki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
dr.naderisorki@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Naderi Soraki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
dr.naderisorki@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Naderi Soraki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
dr.naderisorki@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
Email to dr.naderisorki@mazums.ac.ir
What processes are involved for a request to access data/document
After communicating with the email if available, data and results will be available