Hyperphosphatemia is a basic complication in dialysis patients.a new medicine which is named Niasin Amid is used to cure this illness.for this aim 70 patients will be chosen. it will be divided into two groups :treatment group and experimental group.the experimental group will take Placebo
Exclusion criteria:the dialysis patients must have more than 15 years and they must have been dialized for more than 6 months although they are receiving medicine for Hyperphosphatemi ,their phosphaor is more than 5/5.
exclusion criteria:patients' decision to drop out the associations,or finding of side effects.
Niasin Amid will be taken for 6-8 weeks and the effects will be investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011295275N1
Registration date:2011-04-11, 1390/01/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-11, 1390/01/22
Registrant information
Name
Masoud Sefidmoyeazar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 4854
Email address
drtayebikh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences and Health Services & Razi medicine Co. Ltd.
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect Nicotinamide supplementation on
Hyperphosphatemia in Patients Undergoing Hemodialysis
Public title
Treatment hyperphosphatemia in hemodialysis patient
Purpose
Treatment
Inclusion/Exclusion criteria
include criteria:
1)age>15
2)phosphore>5.5
3)more than 6 month to beginning in hemodialysis
exclude criteria:
1)patient refuse
2)drug adverse
Age
From 15 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Medical University
Street address
Tabriz Medical school, Golgasht St., Tabriz
City
Tabriz
Postal code
Approval date
2010-11-21, 1389/08/30
Ethics committee reference number
22876ئ
Health conditions studied
1
Description of health condition studied
hyperphosphatemia in hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
hyperphosphatemia
Timepoint
once two weeks
Method of measurement
serum phosphor checked
Secondary outcomes
1
Description
HDL
Timepoint
Once two weeks
Method of measurement
HDL in serum checked
2
Description
PTH
Timepoint
Once two weeks
Method of measurement
PTH in serum checked
Intervention groups
1
Description
Intervention 1 giveniacinamide at 500 mg/d (as 250 mg twice daily) to expermental group
Category
Treatment - Drugs
2
Description
Intrevention 2 placibo give to control group During the 6-8week treament.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
SH Madani hospital Iran
Full name of responsible person
Etemadi MD. Nephrelogist
Street address
University St.
City
Tabriz
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Tayebi MD. Nephrologist
Street address
Golgasht St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Tayebi khosroshahi MD.
Street address
Tabriz Medical school
City
Tabriz
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, Tabriz University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Masoud Sefid Moye Azar
Position
Internal Medicine resident
Other areas of specialty/work
Street address
Emam reza hospital
City
Tabriz
Postal code
Phone
+98 41 1554 4854
Fax
Email
drtayebikh@tbzmed.ac.ir masoudsefid@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Tayebi khosroshahi MD.
Position
Nephrologist
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 2501
Fax
Email
drtayebikh@tbzmed.ac.ir jalaletemadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Masoud Sefid Moye Azar
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Emam Reza hospital Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1554 4854
Fax
Email
masoudsefid@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)