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Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03111433
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Heba ibrahim Mohamed serag, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Dietary Supplement: Coenzyme Q10 Drug: Insulin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : March 19, 2017
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : January 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Group I
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
Dietary Supplement: Coenzyme Q10
Coenzyme Q10 soft gelatin capsule 100mg

Drug: Insulin
multiple dose insulin injection therapy

Active Comparator: Group II
this group of patients will receive their standard insulin treatment only
Drug: Insulin
multiple dose insulin injection therapy




Primary Outcome Measures :
  1. change in soluble interacellular adhesion molecule level [ Time Frame: three months ]
    it will be assessed at baseline and after three months of treatment



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: patients from 8 to 18 years old.
  2. Outpatient with at least 1 year history of type 1 diabetes mellitus.
  3. Insulin requirement of more than or equal 0.5 U/Kg/day.
  4. Approval to participate and give informed consent.

Exclusion Criteria:

  1. Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
  2. Preexisting cardiovascular disease or hypertension.
  3. Chronic kidney disease or chronic liver disease.
  4. Significant mental illness.
  5. Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
  6. Intake of coenzyme Q10 within the last 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111433


Locations
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Egypt
Ainshams university pediatric's hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Heba ibrahim Mohamed serag, teaching assistant in clinical pharmacy department ,faculty of pharmacy , Ainshams university, Ain Shams University
ClinicalTrials.gov Identifier: NCT03111433     History of Changes
Other Study ID Numbers: PHCL136
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

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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

Keywords provided by Heba ibrahim Mohamed serag, Ain Shams University:
Type 1 Diabetes mellitus
Coenzyme Q10
endothelial dysfunction
pediatric patients

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Ubiquinone
Coenzyme Q10
Hypoglycemic Agents
Physiological Effects of Drugs
Micronutrients
Nutrients
Growth Substances
Vitamins