In a clinical trial study, 44 hemodialysis patients who were qualified to enter the research were selected and allocated randomly in two groups: an intervention group (n=22) and a control group (n=22).The present study aims to investigate the effects of high protein oral nutritional supplements on dialysis adequacy. Patients in hemodialysis ward of Baqiyatallah Azam Hospital were informed about the research and filled out a written consent. In intervention group, as prescribed and controlled by nutritionists and nephrologists, a cup (24 gr) of Iso-Whey protein powder from pharmaceutical company as well as Karen nutritional-critical supplements were used for two months on daily basis. For both groups, before intervention and one and two months after intervention dialysis adequacy was measured based on URR and Kt/V along with a series of laboratory parameters as well as investigation of nutritional status according to mental comprehensive assessment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209088650N5
Registration date:2015-01-15, 1393/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-15, 1393/10/25
Registrant information
Name
Abbas Ebadi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6057
Email address
ebadi1347@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing Faculty, Baqiyatallah University of Medical SciencesNephrology and Urology Research Center, Baqiyatallah University of Medical SciencesExercise Physiology Research Center, Baqiyatallah University of Medical SciencesNutrition Research Center, Baqiyatallah University of Medical Sciences,
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-11-06, 1393/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of high protein oral nutritional supplement on dialysis adequacy in hemodialysis patients
Public title
Effect of nutritional supplementation on dialysis adequate
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent to participate in research
Albumin less than 4 g per deciliter before the study.
At least 6 months have been treated with hemodialysis.
Older than 18 and younger than 75 years
Hemodialysis: two or more times per week
35kg/m2 >BMI> 18.5 kg / m2
Absence of acute infection
Absence of heart failure or severe respiratory
Absence of chronic inflammatory disease with unknown sources
Not using immunosuppressive drugs
Absence of parenteral nutrition
Absence of recent surgery or during follow up over the past three months.
Absence of chronic liver disease
Absence of nephritic syndrome
Absence of cancer, dementia, Neurological Disease
Absence of hepatitis B, hepatitis C, HIV, infection in the last 4 weeks
Exclusion criteria:
Allergic complications caused by oral nutritional supplements
Confirmation of any problems that the inclusion criteria listed during the study.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
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
The ethics committee of the Baqiyatallah University of Medical Sciences
Street address
sheykh bahayi St, mollasadra Ave, vanak Squ.
City
Tehran
Postal code
Approval date
2014-11-02, 1393/08/11
Ethics committee reference number
5904/5/340
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Dialysis adequacy
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
DaugirddasII
2
Description
Dialysis adequacy
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
URR=BUN1-BUN2/BUN1
Secondary outcomes
1
Description
Albomin
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
Blood tests
2
Description
Total Iron Binding Capacity
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
Blood tests
3
Description
Blood Urea Nitrogen
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
Blood tests
4
Description
Calcium
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
Blood tests
5
Description
Phosphorus
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
Blood tests
6
Description
Creatinine
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
Blood tests
7
Description
Sodium
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
Blood tests
8
Description
Potassium
Timepoint
Baseline, one month after the start of intervention, two months after the intervention.
Method of measurement
Blood tests
Intervention groups
1
Description
Intervention group: Isowhey oral nutritional supplement daily - a cup (24 grams) for two months.
Category
Prevention
2
Description
Control group: No action
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Nursing Faculty, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Ali Rahmani
Street address
Baqiyatallah University of Medical Sciences,Sheykh Bahayi St, Mollasadra Ave, Vanak Squ, Tehran, Iran
City
Tehran
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 of Nursing Faculty, Baqiyatallah University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Exercise Physiology Research Center, Baqiyatallah University of Medical Sciences,
Full name of responsible person
Dr Vahid Sobhani
Street address
Baqiyatallah University of Medical Sciences,Sheykh Bahayi St, Mollasadra Ave, Vanak Squ, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exercise Physiology Research Center, Baqiyatallah University of Medical Sciences,
Proportion provided by this source
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
3
Sponsor
Name of organization / entity
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences,
Full name of responsible person
Dr Behzad Einollahi
Street address
Baqiyatallah University of Medical Sciences,Sheykh Bahayi St, Mollasadra Ave, Vanak Squ, , Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences,
Proportion provided by this source
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
4
Sponsor
Name of organization / entity
Nutrition Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Mohammad Samadi
Street address
Baqiyatallah University of Medical Sciences,Sheykh Bahayi St, Mollasadra Ave, Vanak Squ, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Research Center, Baqiyatallah University of Medical Sciences
Proportion provided by this source
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
Nursing Faculty, Baqiyatallah University of Medical Sciences
Full name of responsible person
Effat Afaghi
Position
MSc student
Other areas of specialty/work
Street address
Nursing Faculty, Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2288 9941
Fax
Email
effat.afaghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Faculty, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Abbas Ebadi
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Faculty, Baqiyatallah University of Medical Sciences
City
tehran
Postal code
Phone
+98 21 2288 9941
Fax
Email
ebadi1347@bmsu.sc.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)