Evaluation of the effect of zinc sulfate on dry mouth improvement in dialysis patients
Determination of the effect of zinc sulfate consumption on improving taste sensation in dialysis patients
Determination of the relationship between zinc blood level and dysgeusia
Determination of the relationship between blood level of zinc and dry mouth
Design
Clinical efficiency with control group, which patients are divided into two groups of 25 persons as unelected. This study was designed as randomize controlled efficiency.
Settings and conduct
Patients will be selected from dialysis ward of Namazi Hospital in Shiraz where participants are blinded and the study is one-sided.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: no active infection, no active cancer, no active heart disease, age group of 18-70 years and minimum onset of dialysis for 6 months.
Intervention groups
The population in this study consisted of dialysis patients referred to Namazi Hospital, out of 100 hemodialysis patients who are dialysis in Namazi Hospital, 50 patients will be voluntarily divided into two groups of 25 patients, the duration of the study is 8 weeks, and one group receives zinc supplement with a dose of 100 mg daily and the other group receives placebo. receives
Main outcome variables
Improving taste sense and dry tongue in patients undergoing chronic hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220808055636N1
Registration date:2022-08-20, 1401/05/29
Registration timing:prospective
Last update:2022-08-20, 1401/05/29
Update count:0
Registration date
2022-08-20, 1401/05/29
Registrant information
Name
Sakine Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3823 7822
Email address
sakihashemi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral zinc sulfate supplementation on improving taste and dry mouth in patients undergoing chronic hemodialysis
Public title
The effect of zinc sulfate on taste and dry mouth in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No active infection
No active cancer
No active heart disease
Age group of 18-70 years
Minimum onset of dialysis is 6 months.
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to perform Concealment, the table of the control group, as well as the drug cans, one including placebo and the other including zinc sulfate, will be provided to a person except the interviewer and evaluator, and the mentioned number will be placed on the cans and the evaluator will be unaware of which number belongs to each grocer.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
No23,Abolfathi Blvd, Fallahi Ave, Pasdaran Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7185734871
Approval date
2022-08-12, 1401/05/21
Ethics committee reference number
IR.SUMS.MED.REC.1401.178
Health conditions studied
1
Description of health condition studied
Evaluation of dysgeusia and dry tongue in patients undergoing chronic hemodialysis
ICD-10 code
XVIII
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Percentage of patients with dysgeusia and dry mouth in chronic hemodialysis patients
Timepoint
Evaluate dry mouth and dysgeusia at the beginning of the study and 8 weeks after taking zinc sulfate tablets
Method of measurement
Dry mouth and dysgeusia questionnaire
Secondary outcomes
1
Description
Increased blood zinc levels in patients
Timepoint
Measurement of zinc blood level at the beginning of the study and 8 weeks after the beginning of the study
Method of measurement
Measurement of zinc blood level by blood test
Intervention groups
1
Description
Intervention group: The society of Amari in this study is dialysis patients referred to Namazi hospital that out of 100 hemodialysis patients who are dialysis in Namazi Hospital, 50 patients voluntarily and in case of no concurrent disease, participate in the present study. Patients are divided into two groups of 25 people, one group receives zinc supplement at a dose of 100 mg daily and the other group receives placebo .At the beginning of the study, dysgeusia and dry mouth questionnaires are filled by patients' and scoring is done and a blood sample is taken to determine serum zinc levels. . At the end of the study, the dysgeusia and dry mouth questionnaire will be filled again and the status change will be evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Sakine Hashemi
Street address
No23,Abolfathi Blvd, Fallahi Ave, Pasdaran Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7185734871
Phone
+98 71 3823 7822
Email
sakihashemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarpour
Street address
No23,Abolfathi Blvd, Fallahi Ave, Pasdaran Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7185734871
Phone
+98 71 3823 7822
Email
sakihashemi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sakine Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No23,Abolfathi Blvd, Fallahi Ave, Pasdaran Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7185734871
Phone
+98 71 3823 7822
Email
sakihashemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sakine Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No23,Abolfathi Blvd, Fallahi Ave, Pasdaran Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7185734871
Phone
+98 71 3823 7822
Email
sakihashemi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sakine Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No23,Abolfathi Blvd, Fallahi Ave, Pasdaran Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7185734871
Phone
+98 71 3823 7822
Email
sakihashemi@yahoo.com
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Potential data can be shared after people are identified.
When the data will become available and for how long
One month after printing the results
To whom data/document is available
Academic and Scientific Institutions
Under which criteria data/document could be used
No special conditions requiredس
From where data/document is obtainable
sakihashemi@yahoo.com
What processes are involved for a request to access data/document