This was a randomized, double-blind study designed for determination of the effect of oral nicotinamide on serum phosphorus in hemodialysis patients. The study population was hemodialysis patients attending Imam Khomeini and Golestan hospitals of Ahvaz. Forty-six eligible hemodialysis patients with age above 18 and serum phosphorus >=5 mg/dl and good cooperation who weren't affected by liver or active peptic disease were randomized to two groups, Nicotinamide (treatment group) and placebo, and were studied for two months. Oral Nicotinamide is administered to treatment group for 8 weeks, 500 mg daily (in two divided doses) for first 4 weeks and 1000 mg daily (in two divided doses) for the second four weeks. Since the primary outcome is the change in serum phosphorus, the fasting serum phosphorus was measured at the beginning, at week 5 and week 9. Also serum lipids and iPTH were measured before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809172817N1
Registration date:2010-02-16, 1388/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-16, 1388/11/27
Registrant information
Name
Azita Zafar Mohtashami
Name of organization / entity
Ahvaz jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 1330
Email address
azmohtashami@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2010-01-15, 1388/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of oral Nicotinamide effects on serum phosphorus in hemodialysis patients in Imam Khomeini and Golestan hospitals of Ahvaz in 2010
Public title
Assessment of oral Nicotinamide effects on serum phosphorus in hemodialysis patients in Imam Khomeini and Golestan hospitals of Ahvaz in 2010
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age>18 years old, hemodialysis for more than 3 months, constant use of phosphate binder in recent two weeks, serum phosphorus>=5
Exclusion Criteria: liver disease or significant disturbance in liver function tests, active peptic ulcer, poor cooperation, severe diarrhea
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapour University of Medical Sciences
Street address
Golestan, Campus of the University
City
Ahvaz
Postal code
Approval date
2010-01-17, 1388/10/27
Ethics committee reference number
پ/8/20/4101
Health conditions studied
1
Description of health condition studied
Hemodialysis patients (ESRD)
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
Serum phosphorus
Timepoint
week 0, 5 and 9 of the study
Method of measurement
serum phosphorus measurement by biochemistry autoanalyser
Secondary outcomes
1
Description
Serum iPTH
Timepoint
before and after the intervention
Method of measurement
Chemiluminescence iPTH measurement
2
Description
Serum lipids
Timepoint
before and after the intervention
Method of measurement
serum biochemistry by autoanalyser
Intervention groups
1
Description
Placebo administered as tablets to control group for two months.
Category
Placebo
2
Description
Oral Nicotinamide is administered to intervention group for 8 weeks: 500 mg daily in two doses for first 4 weeks and 1000 mg daily in two doses for the second four weeks.
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Miss Khodashenas, Mrs Shehni
Street address
Imam Khomeini Hospital of Ahvaz
City
Ahvaz
2
Recruitment center
Name of recruitment center
Golestan Hospital of Ahvaz
Full name of responsible person
Mrs Kadkhodazadeh
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Miss Jaderi
Street address
Golestan boulevard, Campus of the university
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondishapour University of Medical Sciences
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
Golestan Hospital - Ahvaz University of Medical sciences
Full name of responsible person
Dr. Azita Zafar Mohtashami
Position
Fellowship of Nephrology
Other areas of specialty/work
Street address
Golestan Hospital
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
+98 61 1374 3013
Email
azmohtashami@ajums.ac.ir azmohtashami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Heshmatolah Shahbazian
Position
Associate professor - Director of internal medicine
Other areas of specialty/work
Street address
Golestan Hospital
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
+98 61 1374 3013
Email
shahbazian_he@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan Hospital - Ahvaz University of Medical Sciences
Full name of responsible person
Azita Zafar Mohtashami
Position
Fellowship of Nephrology
Other areas of specialty/work
Street address
Golestan Hospital - Nephrology ward
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
+98 61 1374 3013
Email
azmohtashami@ajums.ac.ir, azmohtashami@ yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)