Comparing the effects of Vitamin C and Ferrous Sulfate with Ferrous Sulfate along on Restless leg of hemodialysis patients, a double blind randomized control trial
Determine the effect of vitamin C plus iron in the treatment of Restless leg syndrome of hemodialysis patients
Design
This double blind clinical trial is performed on 80 patients with Restless leg syndrome that randomly divided into two equal groups In parallel. Block randomization method will be used for random allocation. The blocks size will be 4 and for this purpose; 20 blocks with 4 subjects in each block will be used. For selecting each blocks; dice drooped and the block number will be selected. This procedure continued to completed the allocation and reached to sample size.
Settings and conduct
This study was conducted as a clinical trial study with 80 patients who referred to hemodialysis ward of Imam Hossain Hospital of Shahroud. Patients must sign an informed consent form before entering the study. In this study; patients, clinical caregiver and the analyzer was blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged over 15 and under 70 years; definitive diagnosis of restless leg syndrome; the absence of underlying disorders of the skeletal system and the satisfaction in the research.
Exclusion criteria: Patient's unstable hemodynamics; the need to kidney transplantation before the completion of the study; the presence of abnormalities in the skeletal system and the dissatisfaction n the research.
Intervention groups
Patients entered into the study are divided into intervention and control groups. In the intervention group; treatment with vitamin C plus ferrous sulfate will be prescribed in the third month. In the control group; treatment with just ferrous sulfate tablet in the third month will be performed.
Main outcome variables
Reduced severity of Restless leg syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N15
Registration date:2019-04-25, 1398/02/05
Registration timing:registered_while_recruiting
Last update:2019-04-25, 1398/02/05
Update count:0
Registration date
2019-04-25, 1398/02/05
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
Vice chancellor for research of university
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Vitamin C and Ferrous Sulfate with Ferrous Sulfate along on Restless leg of hemodialysis patients, a double blind randomized control trial
Public title
Evaluation effects of Vitamin C and Ferrous Sulfate in Restless leg treatment of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under regular hemodialysis
Age over 15 and under 70 years of patients
Definitive diagnosis of restless leg syndrome
No specific medication associated with restless leg therapy in the last two weeks
The absence of underlying disorders of the skeletal system
Having of satisfaction in research
Exclusion criteria:
Need to kidney transplant before study completion
Hyperparathyroidism
The presence of any underlying abnormalities of the skeletal system
Unstable of vital signs and hemodynamic
Dissatisfaction in research
Age
From 15 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block. Random unit: individual. Randomization tool: statistical software. Sequence building: using randomized 4 in 4 blocks. Hiding method: use envelopes in the package.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients; clinical caregiver and analyzer it are blinded.
The division of patients into two groups A and B is done by a qualified nurse who has no knowledge of the actions performed in the two groups.
Do clinical examination of patients and results recorder will be done by a qualified nurse without any knowledge of the type of intervention and patients.
Placebo
Not used
Assignment
Parallel
Other design features
Patients entered into the study are divided into two groups of intervention and control. Patients in the intervention group; in addition to get the iron pill, will also receive vitamin C tablets. Patients in the control group will be only receive iron tablets.
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
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SHMU.REC.1397.223
Health conditions studied
1
Description of health condition studied
Restless legs syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders
Primary outcomes
1
Description
Severity of Restless Leg Syndroum
Timepoint
Once a Month
Method of measurement
Standard Questioner of Restless Leg syndrome evaluation
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group; treatment with vitamin C tablets plus ferrous sulfate tablets with initial dose of vitamin C (250 mg) plus a ferrous sulfate (60 mg) daily in the first month; two tablets of vitamin C (500 mg) plus two Ferrous sulfate tablets (120 mg) in the second month and 3 tablets of vitamin C (750 mg) plus three tablets of Ferrous sulfate (180 mg) in the third month will be prescribed.
Category
Treatment - Drugs
2
Description
Control group: In the control group; treatment will be done only one Ferrous sulfate tablet (60 mg) in the first month; two tablets of Ferrous sulfate (120 mg) in the second month and three tablets of Ferrous sulfate (180 mg) in the third month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Dr.Monireh Amerian
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
amerian1060@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research; Shahroud University medical and 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?
Yes
Title of funding source
Vice chancellor for research; Shahroud University medical and Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
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@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Monireh Amerian
Position
Nephrologist
Latest degree
Subspecialist
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
amerian1060@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical science
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
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