The efficacy of vitamin D treatment on magnesium levels and prevention of Hypomagnesemia (serum Mg level ≤ 1.7 mg/dl) in chronic hemodialysis patient
Design
This is a clinical trial study with parallel groups, double-blinded randomized, will be conducted on 60 chronic hemodialysis patient. Assignment of patients to the study groups will be done by random-numbers table and using computer.
Settings and conduct
This study will be performed on chronic hemodialysis patients referring to Imam Khomeini Hospital in Ahvaz. At least 60 patients will be randomly assigned to one of two treatment groups. The patients and experimenters will not know about type of treatment and patient grouping and thus until the end of trial the study will be remained double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age more than 18 years, hemodialysis patients who have been on dialysis for at least three months, vitamin D level less than 30 ng/mL, consent to participate in the study; Exclusion criteria: any active or chronic infection, magnesium supplementation, chronic diarrhea, hyperparathyroidism
Intervention groups
In first group, Calcium with D3 500 mg tablets (Dineh CO., Iran) every 12 hours will be prescribed for 3 months. In the second group, oral Pearl Vit D3-50000 unit per week (Dana Pharma CO., Iran) will be prescribed for 3 months.
Main outcome variables
Serum magnesium and vitamin D levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210314050698N1
Registration date:2021-04-03, 1400/01/14
Registration timing:prospective
Last update:2021-04-03, 1400/01/14
Update count:0
Registration date
2021-04-03, 1400/01/14
Registrant information
Name
Ebrahim Hamreh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5222 2621
Email address
ehamreh1366@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D treatment on magnesium levels in chronic hemodialysis patients
Public title
Effect of vitamin D treatment on magnesium levels in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
Hemodialysis patients who have been on dialysis for at least three months
Vitamin D level less than 30 ng/mL
Consent to participate in the study
Exclusion criteria:
Any active or chronic infection
Magnesium supplementation
Chronic diarrhea
Hyperparathyroidism
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random-numbers table and using computer, and on this basis patients will be included in one of the two treatment groups. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention (receiving oral Calcium with D3 500 mg Tabs or Pearl Vit D3-50000) and patient evaluation will be carried out by a physician who is blinded to placement in treatment groups. Also patients and statistical analyzer will not know about patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.172
Health conditions studied
1
Description of health condition studied
Chronic hemodialysis patients
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Serum magnesium level
Timepoint
Before and after treatment (three months later)
Method of measurement
Based on laboratory results measured by magnesium kit (Pars Azmoon,Iran)
2
Description
Serum vitD (25-OH-VitD) level
Timepoint
Before and after treatment (three months later)
Method of measurement
Based on laboratory results measured by Vit D kit (Monobind,Iran)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, oral Pearl Vit D3-50000 unit per week (Dana Pharma CO., Iran) will be prescribed for 3 months.
Category
Prevention
2
Description
Intervention group: In this group, Calcium with D3 500 mg tablets (Dineh CO., Iran) every 12 hours will be prescribed for 3 months.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ebrahim Hamreh
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
ehamreh1366@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3373 8383
Email
badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ebrahim Hamreh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 5222 2621
Fax
Email
ehamreh1366@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ebrahim Hamreh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 5222 2621
Fax
Email
ehamreh1366@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ebrahim Hamreh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 5222 2621
Fax
Email
ehamreh1366@gmail.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
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