The main aim of this study is to check the effect of camel milk on glomerular filtration rate in chronic kidney disease. This study is a randomized clinical trial on patients with chronic kidney disease aged 15 to 60 years. Patients with chronic kidney disease concomitant uncontrolled diabetes or hypertension, cancer patients, patients with urinary obstruction, the fifth stage of chronic kidney disease , patients with acute infection and feverish, patients who are taking nephrotoxic drugs, patients with heart failure, liver failure, polycystic kidney, patients who had kidney transplant and … are excluded. The total number of 60 patients is taken into account that randomly will be divided into two groups: intervention and control .The control group will receive only routine treatment. The intervention group will receive 400 ml camel milk daily for three months in addition to routine treatment. The study period is three months. The main outcome measure of the study is glomerular filtration rate and related consequences outcome are serum creatinine, serum albumin, urinary albumin ,
serum sodium and potassium ,blood uric acid, lipid profile, HbA1c, FBS, blood pressure, The 24 hours urine protein that are measured at the beginning of the study, middle of the study and the end of the study. Serum alkaline phosphatase, serum PTH, calcium, CRP, Hb, kidneys Size are related consequences outcome that are measured at the beginning and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121531427N1
Registration date:2017-02-25, 1395/12/07
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-02-25, 1395/12/07
Registrant information
Name
Amirparviz Tavassoli
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
tavassolyap1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-12-06, 1396/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of camel milk and current treatments on glomerular filtration rate in patients with chronic kidney disease
Public title
The effect of camel milk on chronic kidney diseae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with chronic kidney disease; aged 15 to 60 years.Exclusion criteria: Patients with chronic kidney disease concomitant uncontrolled diabetes(Hb A1c greater than 7 and fasting blood sugar greater than 130); Patients with uncontrolled hypertension(systolic blood pressure of 160 mm Hg and higher and diastolic blood pressure of 100 mm Hg and higher); cancer patients; patients with urinary obstruction; the fifth stage of chronic kidney disease; patients with acute infection and feverish; patients who are taking nephrotoxic drugs; patients with heart failure; liver failure; polycystic kidney; pregnancy; patients who had kidney transplant; lack of satisfaction of continued cooperation in the study; smokers and drug addicts; Patients with chronic kidney disease who are suffering from acute kidney failure.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done with table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave.
City
Mashhad
Postal code
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.MUMS.REC.1395.437
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, stage 1
ICD-10 code
N18.1
ICD-10 code description
Kidney damage with normal or increased GFR (> 90 mL/min)
2
Description of health condition studied
Chronic kidney disease, stage 2
ICD-10 code
N18.2
ICD-10 code description
Kidney damage with mild decreased GFR (60-89 mL/min)
3
Description of health condition studied
Chronic kidney disease, stage 3
ICD-10 code
N18.3
ICD-10 code description
Kidney damage with moderately decreased GFR (30-59 mL/min)
4
Description of health condition studied
Chronic kidney disease, stage 4
ICD-10 code
N18.4
ICD-10 code description
Kidney damage with severely decreased GFR (15-29 mL/min)
Primary outcomes
1
Description
Glomerular filtration rate
Timepoint
Before the intervention, 45 days after the intervention, the end of intervention
Method of measurement
Cockcroft gault Formula
Secondary outcomes
1
Description
Hb
Timepoint
The beginning of the study, the end of the study
Method of measurement
آزمایش خون
2
Description
Urinary albumin
Timepoint
The beginning of the study,middle of the study, the end of the study
Method of measurement
Evaluation of urine
3
Description
24 hour urine protein level
Timepoint
The beginning of the study,middle of the study, the end of the study
Method of measurement
24 hour urine evaluation
4
Description
Serum alkaline phosphatase levels
Timepoint
The beginning of the study, the end of the study
Method of measurement
Laboratory blood test
5
Description
Serum PTH level
Timepoint
The beginning of the study, the end of the study
Method of measurement
Laboratory blood test
6
Description
Blood uric acid
Timepoint
Before the intervention, 45 days after the intervention, the end of intervention
Method of measurement
Laboratory blood test
7
Description
Serum calcium
Timepoint
The beginning of the study, the end of the study
Method of measurement
Laboratory blood test
8
Description
Serum sodium
Timepoint
The beginning of the study,middle of the study, the end of the study
Method of measurement
Laboratory blood test
9
Description
Serum potassium
Timepoint
The beginning of the study,middle of the study, the end of the study
Method of measurement
Laboratory blood test
10
Description
Serum Albumin
Timepoint
The beginning of the study,middle of the study, the end of the study
Method of measurement
Laboratory blood test
11
Description
serum CRP levels
Timepoint
The beginning of the study, The end of the study
Method of measurement
Laboratory blood test
12
Description
blood pressure
Timepoint
The beginning of the study,middle of the study, the end of the study
Method of measurement
By Sphygmomanometer
13
Description
kidneys size
Timepoint
The beginning of the study, the end of the study
Method of measurement
Sonography
14
Description
FBS
Timepoint
The beginning of the study,Middle of the study, The end of the study
Method of measurement
Laboratory blood test
15
Description
HbA1C
Timepoint
The beginning of the study,middle of the study, the end of the study
Method of measurement
Laboratory blood test
16
Description
lipid profile
Timepoint
The beginning of the study,middle of the study, the end of the study
Method of measurement
Laboratory blood test
17
Description
Serum creatinine
Timepoint
Before the intervention, 45 days after the intervention, the end of intervention
Method of measurement
Evaluation of serum
Intervention groups
1
Description
The intervention group in addition to routine treatment will receive camel milk a daily dose of 400 ml for three months.
Category
Treatment - Other
2
Description
The control group will receive the routine Treatments
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Educational, Research and Treatment Center
Full name of responsible person
Ammirparviz Tavassoli
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave.
City
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences, Building Qureshi
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 and Technology Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amirparviz Tavassoli
Position
PhD student of Iranian Traditional Medicine and Complementary
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
+98 51 3853 5980
Email
tavassolyap1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sayyid Musa al-Reza Hosseini
Position
Assistant Professor
Other areas of specialty/work
Street address
Qaem Educational, Research and Treatment Center
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
HoseiniMR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirparviz tavassoli
Position
PhD student of Iranian Traditional Medicine and Complementary
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
Email
tavassolyap1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)