Evaluation the efficacy of Dietary Pasturized egg white with and without Niacinamide for phosphorus control in End Stage Renal Disease patients on Haemodialysis
Main goal: Evaluation the efficacy of Dietary egg white with and without Niacinamide for phosphorus control in End Stage Renal Disease patients on Haemodialysis, Inclusion criteria: Inclusion criteria:Hemofialysis patient; Tendency for participating in reserch
Exclusion criteria: Change in life Style; dietary regimen change, physical activity and tension; No tendency for keeping on;
In this study patient unfer supervision of Nephrologist in the dailysis ward of Hajar Hospital will be select and based on inclusion and exclusion criteria will be seperated in 4 groups in each group 23 patient:
1- Will recieve just white egg, 2-Will recieve Just Niacin, 3-Will recieve white egg and Niacin simulatanously and 4- Control group without any thing
Duration of Study is 6 weeks and at the beginning and the end of the study 5 cc blood will obtained by whole satisfication of patients and refrigrated in -30c for checking the FGF-23,Other routin factors including Calcium, Phosphrous, Albumin and PTH will record in specefic checklist untill statiscal analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102226390N5
Registration date:2016-10-27, 1395/08/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-27, 1395/08/06
Registrant information
Name
Ehsan Ghaedi
Name of organization / entity
Ahwaz Jundishapoor ,University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3285
Email address
ghaedi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Dietary Pasturized egg white with and without Niacinamide for phosphorus control in End Stage Renal Disease patients on Haemodialysis
Public title
Effect of white egg and Niacin on hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Hemofialysis patient; Tendency for participating in reserch
Exclusion criteria: Change in life Style; dietary regimen change, physical activity and tension; No tendency for keeping on
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Rahmatieh, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
8816754633
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
IR.SKUMS.REC.1395.132
Health conditions studied
1
Description of health condition studied
Patient under hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Calcium
Timepoint
befor and after
Method of measurement
Lab Kit
2
Description
Phosphrous
Timepoint
befor and after
Method of measurement
Lab Kit
3
Description
Albumin
Timepoint
befor and after
Method of measurement
Lab Kit
4
Description
Parathormon
Timepoint
befor and after
Method of measurement
Lab Kit
5
Description
Fibroblast Growth Factor 23
Timepoint
befor and after
Method of measurement
Lab Kit
Secondary outcomes
1
Description
wieght
Timepoint
befor and after
Method of measurement
sensitive Balance
Intervention groups
1
Description
Intervention: patient will recive Pasteurized whit egg for 6 weeks as 24gram protein
Category
Treatment - Drugs
2
Description
Intervention: Patients will recieve Niacin 600 mg for 6 weeks
Category
Treatment - Drugs
3
Description
Intervention: patient will recieve Pasteurized white egg and (24 gram protein) and Niacin 600 mg for 6 weeks
Category
Treatment - Drugs
4
Description
Control: continue conventional treatmen along with intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Parisa Javadian
Street address
Nurse st. Hajar Hospital
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Seyed Kamal Solati
Street address
Rahmatieh, Shahrekord University of Medical Sciences
City
ShahreKord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Parisa Javadian
Position
Nephrologist
Other areas of specialty/work
Street address
Nurse st. Hajar Hospital
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
javadianp@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hajar Hospital Research Center
Full name of responsible person
Ehsan Ghaedi
Position
Nutritionist
Other areas of specialty/work
Street address
Hajar Hospital, Research Center
City
Shahrekord
Postal code
Phone
+98 38 3225 2416
Fax
Email
en7cyrus@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hajar Hospital Research Center
Full name of responsible person
Ehsan Ghaedi
Position
Nutritionist
Other areas of specialty/work
Street address
Hajar Hospital Research Center
City
Shahrekord
Postal code
Phone
+98 38 3225 2416
Fax
Email
en7cyrus@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)