Efficacy of Niacin in reduction of phosphate and PTH in hemodialysis patients
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 3 on 60 patients.
Settings and conduct
Sixty hemodialysis patients of Hajar Hospital in Shahrekord Dialysis Center will be screened based on the latest phosphorus serum level in monthly tests and study inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 15 years, Phosphorus more than 4.5, At least six months have passed since the start of hemodialysis, No change in treatment and hemodialysis protocols in the last two weeks and Consent to participate in the study. Exclusion criteria: Pregnancy, Known liver diseases, Active peptic ulcer disease, Taking carbamazepine and Drug intolerance
Intervention groups
Intervention group: Niacin 50 mg tablets. Control group: placebo
Main outcome variables
Level of calcium, phosphate and PTH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190702044076N2
Registration date:2022-11-09, 1401/08/18
Registration timing:prospective
Last update:2022-11-09, 1401/08/18
Update count:0
Registration date
2022-11-09, 1401/08/18
Registrant information
Name
Faranak sadat Filsous
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 8907
Email address
hamidnasri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of niacin on sodium, phosphorus, parathyroid hormone (PTH) and vitamin D levels in hemodialysis patients
Public title
The effect of niacin on sodium, phosphorus, parathyroid hormone (PTH) and vitamin D levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 15 years
Phosphorus more than 4.5
At least six months have passed since the start of hemodialysis
No change in treatment and hemodialysis protocols in the last two weeks
Consent to participate in the study
Exclusion criteria:
Pregnancy
Known liver diseases
Active peptic ulcer disease
Taking carbamazepine
Drug intolerance
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The type of drug prescribed is randomized by simple randomization among the participants by using the RRApp software. For this purpose, in the order of participation in the research, the participants will receive Niacin (N=30) or placebo (N=30)based on the group they are assigned by RRApp software. Allocation concealment is not carried out. http://clinicalresearch-apps.com/RRApp.html
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients knowing about the study groups will not be informed about the allocation in treatment groups and this allocation will be done randomly. The statistical analyzer will receive the groups as A and B codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord of Medical Sciences
Street address
Num 21/shahid yar mohammadi alley/Bagh ziar Blve
City
Esfahan
Province
Isfehan
Postal code
8177774564
Approval date
2022-06-22, 1401/04/01
Ethics committee reference number
IR.SKUMS.REC.1400.079
Health conditions studied
1
Description of health condition studied
Dialysis
ICD-10 code
T81.502
ICD-10 code description
Unspecified complication of foreign body accidentally left in body following kidney dialysis
Primary outcomes
1
Description
Calcium
Timepoint
Before intervention, month 1, 2 and 3
Method of measurement
Blood sampling
2
Description
Parathyroid hormone
Timepoint
Before intervention, month 1, 2 and 3
Method of measurement
Blood sampling
3
Description
Phosphorus
Timepoint
Before intervention, month 1, 2 and 3
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group of patients will take 50 mg niacin tablets daily
Category
Treatment - Drugs
2
Description
Control group: This group of patients will receive placebo tablets similar to niacin tablets daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital in Shahrekord
Full name of responsible person
Faranak Sadat Filsouf
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 5505
Email
Hajar-Hospital@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Masoumeh Moezzi
Street address
Rahmatiyeh Street
City
Shahrekord
Province
Isfehan
Postal code
8815716191
Phone
+98 38 3333 9940
Email
mmoezzi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahrekrd University of Medical Science
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Faranak Sadat Filsous
Position
General docter
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No21/Shahid Yarmohammadi Ave/Bagh Ziar Blvd
City
Esfahan
Province
Isfehan
Postal code
8815716191
Phone
+98 31 3778 8907
Fax
Email
hamidnasri@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Faranak Sadat Filsous
Position
General docter
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No21/Shahid Yarmohammadi Ave/Bagh Ziar Blvd
City
Esfahan
Province
Isfehan
Postal code
8815716191
Phone
+98 31 3778 8907
Fax
Email
hamidnasri@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Faranak Sadat Filsous
Position
General docter
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No21/Shahid Yarmohammadi Ave/Bagh Ziar Blvd
City
Esfahan
Province
Isfehan
Postal code
8815716191
Phone
+98 31 3778 8907
Fax
Email
hamidnasri@med.mui.ac.ir
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