Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

April 1, 2018 updated by: Heba ibrahim Mohamed serag, Ain Shams University

Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ainshams university pediatric's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in soluble interacellular adhesion molecule level
Time Frame: three months
it will be assessed at baseline and after three months of treatment
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2017

Primary Completion (Actual)

January 20, 2018

Study Completion (Actual)

January 20, 2018

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

April 1, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHCL136

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on Coenzyme Q10

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe