Effect of egg white on phosphorus and nutritional and inflammatory factors in hemodialysis patients .
Design
.prospective randomized, non-blinded, interventional study
Settings and conduct
The plan is for all participants who have undergone hemodialysis for at least three months and their phosphorus level is above 5.5mg/dl, it will be explained and the consents of the project participant will be received by all of them then be asked to list their daily diets for 4 weeks on a daily checklist as well as height, weight, and albumin, phosphorus and cholesterol tests, and dialysis adequacy before beginning the egg whites will enter to the checklist. The type and amount of phosphorus lowering drugs used and dialysis type and duration of dialysis will be recorded. Then participants will be randomly divided based on positioning table of numbers, patients with even number were case group and patients with odd numbers were control group. The case group is exposed to an egg white diet. Then at the end of the fourth and eighth week, these patients will have their blood levels of phosphorus and albumin and cholesterol and any changes in the weight and amount of medication used to be recorded in the final checklist.
Participants/Inclusion and exclusion criteria
Entry criteria : 1- Patients who have undergone hemodialysis for at least three months.
2- Their phosphorus content is above 5.5mg/dl.
Exclusion criteria: 1- Egg allergy
Intervention groups
the case group is exposed to an egg white diet regime for eight weeks as a meal at home from a white-tailed egg pack (Telavang Brand) containing six egg whites with 96 calories and 24 grams of protein before beginning the egg whites diet regime and at the end of the fourth and eighth week information will enter to the checklist .
Main outcome variables
Decrease in average phosphorus and increase in albumin and decrease in cholesterol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190701044061N1
Registration date:2019-12-14, 1398/09/23
Registration timing:registered_while_recruiting
Last update:2019-12-14, 1398/09/23
Update count:0
Registration date
2019-12-14, 1398/09/23
Registrant information
Name
Najmeh Shamspour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3121 7243
Email address
n.shamspour@kum.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Egg white On control of Phosphorus in Dialysis Patients
Public title
The Effect Of Egg White On Control of Phosphorus in Dialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been at least three months since the start of hemodialysis
Patients with high phosphorus levels 5.5 mg/dl
Exclusion criteria:
Egg allergy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman intersection of Tahmasb Abad at the beginning of Jehad Boulevard at the beginning of Ibn Sina Stree
City
Kerman
Province
Kerman
Postal code
7619813156
Approval date
2019-12-13, 1398/09/22
Ethics committee reference number
IR.KMU.AH.REC.1398.027
Health conditions studied
1
Description of health condition studied
phosphorus control in dialysis patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
phosphorus
Timepoint
before and after egg white diet in hemodialysis patients at the end of week 4 and 8
Method of measurement
blood level
Secondary outcomes
1
Description
Albumin
Timepoint
before and after receiving of egg white diet in hemodialysis patients at the end of week 4 and 8
Method of measurement
Blood level
Intervention groups
1
Description
Intervention group: case group is exposed to an egg white diet regime for eight weeks as a meal every other day at home from a white-tailed egg pack (Telavang Brand) containing six egg whites with 96 calories and 24 grams of protein
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Najmeh Shamspour
Street address
Shafa Ave . Kerman Town
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
nshamspour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Shamspour
Street address
Shafa Ave . Shafa hospital . Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
nshamspour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
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
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Shamspour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shafa Ave.Shafa hospital .Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5813
Email
nshamspour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Shamspour
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shafa Ave .Shafa hospital.Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5813
Email
nshamspour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Shamspour
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shafa Ave.Shafa hospital .Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5813
Email
nshamspour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Primary outcomes: Decrease in average phosphorus and increase in albumin and decrease in cholesterol
When the data will become available and for how long