A Comparative study on the effet of Niacin and Sevelamer on decreasing the phosphorous in dialysis patients referring to dialysis department of 5azar medical education center of gorgan in2019(1398)
The effect of nicotinic acid and Renagel and the effect of these two drugs on the reduction of phosphorus in hemodialysis patients
Design
Clinical trials without control group, with parallel groups, non-blind, randomized
Settings and conduct
In the first group, niacin will begin with a dose of 500 mg (100 mg tablets), 3 pills in the morning and 2 pills a night. In the second group, the solaamer starts at a dose of 1600 mg (800 mg capsules) 1 morning and 1 time in the evening.
Participants/Inclusion and exclusion criteria
Aged over 18, satisfaction, serum phosphorus higher than 6 mg / dl, initiation of dialysis for more than 3 months, no change in treatment protocols (calcium and vitamin D compounds), and dialysis protocol over the past 2 weeks
Intervention groups
In the first group, niacin will begin with a dose of 500 mg (100 mg tablets), 3 pills in the morning and 2 pills a night. In the second group, the solaamer starts at a dose of 1600 mg (800 mg capsules) 1 morning and 1 time in the evening. All medications should be taken with food.
Main outcome variables
Phosphorus level
Calcium level
Duration of dialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190324043106N1
Registration date:2022-08-05, 1401/05/14
Registration timing:retrospective
Last update:2022-08-05, 1401/05/14
Update count:0
Registration date
2022-08-05, 1401/05/14
Registrant information
Name
amirali falahat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3377 5822
Email address
amirali_aaf1992@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-17, 1398/03/27
Expected recruitment end date
2019-07-18, 1398/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study on the effet of Niacin and Sevelamer on decreasing the phosphorous in dialysis patients referring to dialysis department of 5azar medical education center of gorgan in2019(1398)
Public title
A Comparative study on the effet of Niacin and Sevelamer on decreasing the phosphorous in dialysis patients referring to dialysis department of 5azar medical education center of gorgan in2019(1398)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged over 18
Obtaining consent
Serum phosphorus higher than 6 mg / d
Start the dialysis period for more than 3 months
No change in treatment protocols (calcium and vitamin D compounds) and dialysis protocol over the past 2 weeks
Randomization method: In order to randomize samples, we use a block method with quadrilateral blocks. In this way, one of the following blocks is first selected by accident (for example, with a dice), and according to the order in which those samples are We assign two groups (A for the group receiving Dariviazin and B for the Solamer recipient group). For example, if block 3 is selected and the first one is assigned to the group receiving the drug, and the second and third samples will be allocated to the solamroup recipient group, the fourth will be assigned to the group receiving the drug. Then for four samples, again, a block will be randomly selected. We will allocate it to it and this process will proceed to the end of the sampling.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of golestan university of medical sciences
Street address
gorgan -hircan ave .golestan university of medical sciences
City
gorgan
Province
Golestan
Postal code
61551-49177
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.GOUMS.REC.1398.074
Health conditions studied
1
Description of health condition studied
Chronic kidney patients undergoing hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
P reduction rate
Timepoint
At the beginning of the study and one month later
Method of measurement
blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Niacin Receiving Group / The first group of patients treated with niacin with a dose of 500 mg per day (100 mg tablets from Abtin Chemical Company); 300 mg in the morning and 200 mg at night with food
Category
Treatment - Drugs
2
Description
Intervention group: Renagel Recipient Group/ The second group of patients treated with sevelamer with a dose of 1600 mg (800 mg capsules of Faran Chem Company); 800 mg in the morning and 800 mg at night with food