Evaluation of the effect of vitamin C supplementation on selected blood laboratory indicators of chronic kidney diseases, a double blind randomized control trial
Determining the effect of vitamin C supplementation on selected blood laboratory indicators of chronic kidney patients
Design
This is a parallel randomized controlled clinical trial that will be performed on 106 patients with Chronic renal failure. Randomization in this research is done using quadri blocks using syntax written in SPSS program.
Settings and conduct
This study will conduct as a clinical trial study with 106 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 definitive diagnosis of chronic kidney disease and need dialysis; Age range 15-65 years; History of dialysis for at least six consecutive months; Stable vital signs; Have a controlled and consistent diet throughout the study; Conscious consent to participate in research. Exclusion criteria: Existence of digestive problems such as severe nausea and vomiting;
Existence of severe and relatively severe coagulation problems; Existence of chronic heart and liver disease at the same time; Take any vitamin C supplements in the past month; Any changes in diet without notice during the study; Withdrawal or regret of conducting research at any stage of research.
Intervention groups
For patients in the intervention group, after justifying the patients and providing the necessary training, routine treatment (including: hemodialysis, medication and diet) + 250 mg of vitamin C tablets once a day during the study (12 weeks) is prescribed. For patients in the control group, after justifying the patients and providing the necessary training, only routine treatment (including: hemodialysis, medication and diet) is prescribed during the study (12 weeks).
Main outcome variables
Measurement of serum potassium; Measurement of serum calcium and Blood sugar measurement.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N25
Registration date:2022-01-31, 1400/11/11
Registration timing:prospective
Last update:2022-01-31, 1400/11/11
Update count:0
Registration date
2022-01-31, 1400/11/11
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
2022-02-20, 1400/12/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin C supplementation on selected blood laboratory indicators of chronic kidney diseases, a double blind randomized control trial
Public title
Evaluation of the effect of vitamin C on some blood indicators of dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with definitive diagnosis of chronic kidney disease and need dialysis;
Age range 15-65 years;
History of dialysis for at least six consecutive months;
Stable vital signs;
Have a controlled and consistent diet throughout the study;
Conscious consent to participate in research.
Exclusion criteria:
Existence of digestive problems such as severe nausea and vomiting;
Existence of severe and relatively severe coagulation problems;
Existence of chronic heart and liver disease at the same time;
Take any vitamin C supplements in the past month;
Any changes in diet without notice during the study;
Withdrawal or regret of conducting research at any stage of research.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
106
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 106 and number of blocks was 27. Allocation concealment was done using closed opaque envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients; clinical caregiver, outcome evaluator and analyzer it are blinded. The division of patients into two groups intervention and control, review and record test results is done by a qualified nurse who has no knowledge of the actions performed in the two groups. Data analysis will also be performed by a project epidemiologist who has no knowledge of patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
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
2022-01-05, 1400/10/15
Ethics committee reference number
IR.SHMU.REC.1400.236
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.4
ICD-10 code description
Chronic kidney disease, stage 4 (severe)
Primary outcomes
1
Description
Measurement of serum potassium
Timepoint
Once a month
Method of measurement
Standard laboratory method
2
Description
Measurement of serum calcium
Timepoint
Once a month
Method of measurement
Standard laboratory method
3
Description
Blood sugar measurement
Timepoint
Once a month
Method of measurement
Standard laboratory method
4
Description
Measurement of hemoglobin
Timepoint
Once a month
Method of measurement
Standard laboratory method
Secondary outcomes
1
Description
Dialysis adequacy measurement
Timepoint
Once a month
Method of measurement
Dialysis adequacy indicators KT/V
Intervention groups
1
Description
Intervention group: for patients in the intervention group, after justifying the patients and providing the necessary training, routine treatment (including: hemodialysis, medication and diet) + 250 mg of vitamin C tablets once a day during the study (12 weeks) is prescribed.
Category
Treatment - Drugs
2
Description
Control group: for patients in the control group, after justifying the patients and providing the necessary training, only routine treatment (including: hemodialysis, medication and diet) is prescribed during the study (12 weeks).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Dr. Hoofar Rafiei
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
rafiei@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Imamian
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
Dr. Mehdi Feyzabadi
Position
Internal resident
Latest degree
Medical doctor
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
mehdifyzabadi082@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hoofar Rafiei
Position
Nephrologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
آدرس خیابان 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
rafiei@shmu.ac.ir
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