Protocol summary

Study aim
Study the effect of vitamin E in reducing muscle cramps and pruritus in hemodialysis patients referring to hospitals affiliated to Tehran Azad University.
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 40 patients. Excel rand function was used for randomization.
Settings and conduct
In the dialysis wards of the hospitals affiliated to the Islamic Azad University of Tehran, the two case and control groups will be randomly given vitamin E and placebo for 12 weeks and will be asked a questionnaire at the beginning and end of the study. Patients, physician, researcher and statistician They will be unaware of the type of medicine they will be taking.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 18 to 90 years old; signing of informed consent form; starting dialysis at least three months ago; no history of taking vitamin E at the beginning and before the study; no history of eczema; no history of liver disease; no history of chronic gastrointestinal disease; no history of hypothyroidism; no history of parathyroid hormone above 300 and phosphorus above 6. Exclusion criteria: allergy to vitamin E capsules or placebo; pregnancy or lactation.
Intervention groups
In this randomized study, we have two case and control intervention groups, which we will give 400 units of vitamin E once daily to the case group and placebo once daily to the control group for 12 weeks.
Main outcome variables
Muscle cramps, itching and appetite

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150706023084N10
Registration date: 2021-10-09, 1400/07/17
Registration timing: prospective

Last update: 2021-10-09, 1400/07/17
Update count: 0
Registration date
2021-10-09, 1400/07/17
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-10, 1400/07/18
Expected recruitment end date
2021-12-09, 1400/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin E on muscle cramps, appetite and pruritus in hemodialysis patients in dialysis wards of hospitals affiliated to Islamic Azad University of Tehran
Public title
Trial of vitamin E on pruritus, appetite and muscle cramps in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic kidney disease in the end stages Hemodialysis patients Age range 18 to 90 years old Signature informed consent form Start dialysis at least three months ago
Exclusion criteria:
History of thyroid disease Use of vitamin E Pregnancy Allergy to vitamin E or placebo History of chronic gastrointestinal disease History of chronic dermatologic disease History of liver disease such as cholestasis
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Sample selection and allocation in this study was done randomly with the help of rand function of Excel software. With the help of this software, the sequence of drug and placebo distribution was determined between the two groups of patients and with the help of someone outside the study, the groups receiving the drug and placebo were divided according to the mentioned sequence and the desired compounds were delivered to the patients.This information will be recorded and maintained by the said person until the end of the research.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the physician, researcher, data analyst, and patient taking the drug are unaware of the type of combination they will be taking (drug or placebo) and do not understand what combination they are receiving. The recipients of the drug and placebo were divided and the desired compounds were delivered to the patients and this information will be recorded and kept by the said person until the end of the research.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Department of Pharmaceutical Sciences, Tehran Islamic Azad University of Medical
Street address
No.99, Yakhchal street, Dr.Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2021-09-13, 1400/06/22
Ethics committee reference number
IR.IAU.PS.REC.1400.172

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Muscle cramp score
Timepoint
The time periods of muscle cramp severity were measured at the beginning of the study (before the intervention) and 12 weeks after the start of vitamin E use.
Method of measurement
In the study "the effect of vitamin E supplement on muscle cramps and itching and appetite in hemodialysis patients" how to measure muscle cramps is a questionnaire of professors of Tarbiat Modares University in relation to the evaluation of muscle cramps.

2

Description
Itching score
Timepoint
The time periods of itching severity were measured at the beginning of the study (before the intervention) and 12 weeks after the start of vitamin E use.
Method of measurement
In the study "The effect of vitamin E supplementation on muscle cramps and itching and appetite in hemodialysis patients" is yusovich questionnaire on how to measure itching.

3

Description
Appetite score
Timepoint
The appetite changes were measured at the beginning of the study (before the intervention) and 12 weeks after the start of vitamin E use.
Method of measurement
In the study "The effect of vitamin E supplementation on muscle cramps and itching and appetite in hemodialysis patients" is Bacter and Doyer questionnaire on how to measure appetite .

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 20 hemodialysis patients who will receive 400 units of vitamin E daily after lunch for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: 20 hemodialysis patients who will receive placebo of vitamin E contains oral paraffin daily after lunch for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Booali Hospital, Tehran
Full name of responsible person
Dr. Farahnaz Pasha
Street address
At the beginning of Damavand Street, Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Fax
Email
booali.hospital96@gmail.com
Web page address
http://bouali.iautmu.ac.ir/fa

2

Recruitment center
Name of recruitment center
Farhikhtegan hospital,Tehran
Full name of responsible person
Dr.Farahnaz Pasha
Street address
In front of the Central Organization of Islamic Azad University, north of Daneshgah Square, the end of Sattari
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Email
farhikhteganhospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
No.99,Yakhchal street,Dr.shariati Avenue
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 0056 2264
Email
info@iau.ac.ir
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
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
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Fax
Email
shiehmorteza@iaups.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Fax
Email
shiehmorteza@iaups.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Fax
Email
shiehmorteza@iaups.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...