This parallel randomized clinical trial will be conducted in 50 subjects with chronic kidney disease (GFR<90 mL/min/1.73m2). Subjects in the intervention group will receive 50 g/d oat + nutritional recommendations for patients with chronic kidney disease (CKD). In the control group, only nutritional recommendations will be given to patients. The renal function will be measured by biochemical variables (blood urea nitrogen, serum concentration of creatinine, potassium, albumin, and klotho; and urinary creatinine and proteinuria) at baseline and after 8 weeks of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050414551N2
Registration date:2015-12-10, 1394/09/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-10, 1394/09/19
Registrant information
Name
Mohammad Hossein Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
s_m_rouhani2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Food Security Research Center of Isfahan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oat consumption on renal function in subjects with chronic kidney disease
Public title
Oat and treatment of kidney disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: GFR<90 mL/min/1.73m2, without any disease which interpret with study outcomes, no using medications which interpret with study outcomes, fill the written consent
Exclusion criteria: low adherence to the prescribed diet, loss to fallow up, start using medications which interpret with study outcomes, get disease which interpret with study outcomes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square, Isfahan
City
Isfahan
Postal code
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
IR.MUI.REC.1394.3.192
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified
Primary outcomes
1
Description
Blood Urea Nitrogen
Timepoint
8 weeks
Method of measurement
Biochemistry
2
Description
Serum Creatinine
Timepoint
8 weeks
Method of measurement
Biochemistry
3
Description
Serum Albumin
Timepoint
8 weeks
Method of measurement
Biochemistry
4
Description
Urine Creatinine
Timepoint
8 weeks
Method of measurement
Biochemistry
5
Description
Urine Protein
Timepoint
8 weeks
Method of measurement
Biochemistry
6
Description
parathyroid hormone
Timepoint
8 weeks
Method of measurement
Biochemistry
7
Description
Serum Klotho
Timepoint
8 weeks
Method of measurement
Biochemistry
8
Description
Serum Potassium
Timepoint
8 weeks
Method of measurement
Biochemistry
Secondary outcomes
1
Description
Weight
Timepoint
8 Weeks
Method of measurement
Scale
Intervention groups
1
Description
Intervention group: Nutritional recommendations for patients with chronic kidney disease will be delivered to this group. Subjects are also prescribed to consume 50 gr/day oat powder.
Category
Treatment - Other
2
Description
Control group: Nutritional recommendations for patients with chronic kidney disease will be delivered to this group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal Medical Clinic
Full name of responsible person
Dr Leila Azadbakht
Street address
School of Nutrition and Food Science, Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Mohammad Hasan Entezari
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
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 Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Leila Azadbakht
Position
Ph.D, Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Azadi Square
City
Isfahan
Postal code
Phone
+98 31 3792 3151
Fax
Email
Azadbakht@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Leila Azadbakht
Position
Ph.D
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square
City
Isfahan
Postal code
Phone
+98 31 3792 3151
Fax
Email
Azadbalht@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)