The Effects of Coenzyme Q10 Supplementation in Pediatrics with Chronic Kideny Disease stage 2 - 4 : A Randomized, Paralleled, Double blind, Controlled clinical trial
Proposing a new drug intervention to improve renal function.
Design
Randomized, paralleled, Double blind, controlled clinical trial with sample size of 60 patients
Settings and conduct
After entering the trial, patient will be randomly allocated to intervention and control groups by block randomization process. Physician and patients will be blind in this trial. Blood and urine samples will be taken at time 0 and three months after intervention and results are compared before and after the study and between both groups.
This study will be conducted locally in Ali Asghar Children's Hospital.
Participants/Inclusion and exclusion criteria
Children diagnosed with Chronic Kidney Disease (CKD) stages 2 to 4
Entering criteria:
1.Age between 2 to 18 years old
2.Children diagnosed with CKD stages 2 to 4 based on estimated Glomerular Filtration Rate (eGFR)
Criteria for exclusion:
1.Liver disease
2.Autoimmune diseases
3.Kidney transplantation in last 6 months
4.Taking Corticosteroids and immunosuppressive medication
Intervention groups
After entering the trial, patient will be randomly allocated to intervention and control groups. Patients in the intervention group will take Q10, 3 mg per kg up to 100 mg daily adjuvant to their routine medication. Patients in control group will only receive their routine medication.
The Effects of Coenzyme Q10 Supplementation in Pediatrics with Chronic Kideny Disease stage 2 - 4 : A Randomized, Paralleled, Double blind, Controlled clinical trial
Public title
The Effects of Coenzyme Q10 Supplementation in Pediatrics with Chronic Kideny Disease : A Randomized, Paralleled, Double blind, Controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 2 to 18 years old
Diagnosed with Chronic Kidney Disease stage 2 - 4 according to estimated Glomerular Filtration Rate (eGFR) findings
Exclusion criteria:
Liver disease
Chronic pulmonary disease
Autoimmune disease
Gastrointestinal dysfunction with the need for Parenteral nutrition
Kidney transplantation in last 6 months
Taking Antioxidants such as Vit E , L-Carnitine, or Omega 3 supplements in past 3 months
Taking corticosteroids and/or immunosuppressive medication
Age
From 2 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into control and intervention groups using Blocked Randomization method. In this method, computer generated block sizes of 4 with equal probability will be used to enter eligible patients into one of the groups, intervention (Group B) and control (Group A). Initially one of the blocks will be randomly selected and the blocks will be repeatedly used to enter all eligible patients into one of the two groups.
Patients in the intervention group (Group B) will be treated with the usual treatment regimen, plus Co Q10, 3 mg / kg and up to 100 mg daily for 3 months. In the control group, patients will receive only the usual treatment regimen.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the physician and participants are blind. After the diagnosis of the disease, the physician will give the patients the envelopes on which A or B are written. The patient will deliver the envelope to the investigator, and after checking the inclusion and exclusion criteria of the study, the patient will be assigned to either the control (A) or intervention (B) groups based on the envelopes. Only the investigator knows which group is intervention and which group is control.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.IUMS.REC.1398.407
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Blood Urea Nitrogen level
Timepoint
Before starting an intervention and three months after taking co enzyme Q10 supplement
Method of measurement
Blood test, Photometric kit
2
Description
Creatinine level
Timepoint
Before starting an intervention and three months after taking co enzyme Q10 supplement
Method of measurement
Blood test, photometric kit
3
Description
eGFR
Timepoint
Before starting an intervention and three months after taking co enzyme Q10 supplement
Method of measurement
Calculation based on blood Creatinine and patient's height
4
Description
Proteinuria
Timepoint
Before starting an intervention and three months after taking co enzyme Q10 supplement
Method of measurement
Urine test, Dipstick
Secondary outcomes
1
Description
C-Reactive Protein (CRP) level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, Agglutination method
2
Description
Erythrocyte Sedimentation Rate (ESR) level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, Photometric kit
3
Description
Fasting blood Glucose level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, Photometric test
4
Description
Alanine Aminotransferase (ALT) level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, photometric kit
5
Description
Aspartate Aminotransferase (AST) level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, photometric kit
6
Description
Blood Triglyceride level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, photometric kit
7
Description
Low Density Lipoprotein (LDL) level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, photometric kit
8
Description
High Density Lipoprotein (HDL) level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, photometric kit
9
Description
Total Cholesterol level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Blood test, photometric kit
10
Description
Urine protein level
Timepoint
Before starting the intervention and 3 months after taking co enzyme Q10 supplement
Method of measurement
Urine test, Dipstick method
Intervention groups
1
Description
Intervention group: After entering the trial, patients will be prescribed to take co enzyme Q10 supplement from Nutri Century Corporation 3 mg per kg up to 100 mg daily adjuvant to their routine medication.
Category
Treatment - Drugs
2
Description
Control group: After entering the trial, patients will only receive their routine medications without Q10. Blood and urine tests will be taken at time 0 and three months after taking Q10.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali asghar children's hospital
Full name of responsible person
Pedram Shayesteh
Street address
Zafar street , Modarres Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041
Email
aach@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?