Determining the effect of zinc sulfate on sleep quality in patients undergoing chemotherapy
Design
This is a parallel randomized controlled clinical trial that will be performed on 100 hemodialysis patients with sleep disorders. Randomization in this research is done using quadri blocks using syntax written in SPSS program. The duration of the study will be 2 months.
Settings and conduct
This study will conduct as a clinical trial study with 100 patients who will refer to Imam Hossain Hospital of Shahroud. Patients must sign an informed consent form before entering the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with breast and blood cancer undergoing chemotherapy with low sleep quality (Global Score <5), Chemotherapy for at least the last four months, Perform chemotherapy for at least once every 15 days, Do not take any sleeping drugs for at least the past month and Having informed consent to participate in research.
Exclusion criteria:Patients with cancers other than breast and blood, Use supplements containing zinc or fish oil at least one month before the study,
Existence of severe heart and respiratory diseases for at least one month,
Patients who have had a bone marrow transplant and then returned to chemotherapy, History of severe mental illness for at least the last three months, History of severe mental illness for at least the last three months and
Dissatisfaction with participation in research.
Intervention groups
Patients included in the study are divided into intervention and control groups. In the intervention group, treatment with zinc sulfate tablets will be prescribed. In the control group, placebo treatment will be prescribed.
Main outcome variables
Sleep quality assessment and CRP measurement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N20
Registration date:2020-09-26, 1399/07/05
Registration timing:prospective
Last update:2020-09-26, 1399/07/05
Update count:0
Registration date
2020-09-26, 1399/07/05
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-21, 1399/07/30
Expected recruitment end date
2021-01-18, 1399/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zinc sulfate on sleep quality in chemotherapy patients in Imam Hossain hospital of Shahroud , a randomized clinical trial
Public title
The effect of zinc sulfate on sleep quality in patients undergoing chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast and blood cancer undergoing chemotherapy with low sleep quality (Global Score <5),
Chemotherapy for at least the last four months,
Perform chemotherapy for at least once every 15 days,
Do not take any sleeping drugs for at least the past month,
Having informed consent to participate in research.
Exclusion criteria:
Patients with cancers other than breast and blood
Use supplements containing zinc or fish oil at least one month before the study
Existence of severe heart and respiratory diseases for at least one month
Patients who have had a bone marrow transplant and then returned to chemotherapy
History of severe mental illness for at least the last three months
History of severe mental illness for at least the last three months
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated to intervention and control groups according to random allocation table that illustrated by a statistician. Randomization was done using permuted block randomization method (Block size was 4) using blocked random allocation syntax in SPSS software. For calculation sample size was 100 and number of blocks was 25. Allocation concealment was done using closed opaque envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.SHMU.REC.1398.076
Health conditions studied
1
Description of health condition studied
End-stage renal disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
2
Description of health condition studied
Nonorganic sleep disorders
ICD-10 code
F51
ICD-10 code description
Nonorganic sleep disorders
Primary outcomes
1
Description
Sleep quality assessment
Timepoint
Once a month
Method of measurement
Ask the patient and using the standard Petersberg Sleep Quality Assessment Questionnaire
Secondary outcomes
1
Description
CRP measurement
Timepoint
Once a month
Method of measurement
Laboratory method
Intervention groups
1
Description
Intervention group: Patients in the intervention group are prescribed one 220 mg zinc sulfate tablet daily for the first month and then two zinc sulfate tablets (440 mg) daily for the second month.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group will be given one starch tablet apparently similar to a placebo daily for the first month and then two placebo tablets daily for the second month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
ِDr. Ali Najafi
Street address
Imam Hossein Hospital., End Imam street., Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
anajafi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and 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
Shahroud University of Medical Sciences
Full name of responsible person
Fateme Hasanifard
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
fatemehasanifard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Ali Najafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Hossein hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
anajafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available