Back to resultsEfficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Coenzyme Q10
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 Diabetes mellitus, Coenzyme Q10, endothelial dysfunction, pediatric patients
Eligibility Criteria
Inclusion Criteria:
- Age: patients from 8 to 18 years old.
- Outpatient with at least 1 year history of type 1 diabetes mellitus.
- Insulin requirement of more than or equal 0.5 U/Kg/day.
- Approval to participate and give informed consent.
Exclusion Criteria:
- Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
- Preexisting cardiovascular disease or hypertension.
- Chronic kidney disease or chronic liver disease.
- Significant mental illness.
- Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
- Intake of coenzyme Q10 within the last 3 months.
Sites / Locations
- Ainshams university pediatric's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I
Group II
Arm Description
this group of patients will receive their standard insulin treatment in addition to 100 mg of coenzyme Q10 soft gelatin capsule once daily for three month
this group of patients will receive their standard insulin treatment only
Outcomes
Primary Outcome Measures
change in soluble interacellular adhesion molecule level
it will be assessed at baseline and after three months of treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03111433
Brief Title
Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus
Official Title
Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 19, 2017 (Actual)
Primary Completion Date
January 20, 2018 (Actual)
Study Completion Date
January 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Type 1 Diabetes mellitus, Coenzyme Q10, endothelial dysfunction, pediatric patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
this group of patients will receive their standard insulin treatment in addition to 100 mg of coenzyme Q10 soft gelatin capsule once daily for three month
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
this group of patients will receive their standard insulin treatment only
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Intervention Description
Coenzyme Q10 soft gelatin capsule 100mg
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
multiple dose insulin injection therapy
Primary Outcome Measure Information:
Title
change in soluble interacellular adhesion molecule level
Description
it will be assessed at baseline and after three months of treatment
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: patients from 8 to 18 years old.
Outpatient with at least 1 year history of type 1 diabetes mellitus.
Insulin requirement of more than or equal 0.5 U/Kg/day.
Approval to participate and give informed consent.
Exclusion Criteria:
Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
Preexisting cardiovascular disease or hypertension.
Chronic kidney disease or chronic liver disease.
Significant mental illness.
Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
Intake of coenzyme Q10 within the last 3 months.
Facility Information:
Facility Name
Ainshams university pediatric's hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus
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