Effect of Coenzyme Q10 on Diabetic Children

April 10, 2024 updated by: Christina Saad Abdel Malak Abdel Nour, Assiut University

Efficacy of Coenzyme Q10 Supplementation on Metabolic Control in Children With Type 1 Diabetes Mellitus: a Randomized Clinical Trial

Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 1 diabetes mellitus is an autoimmune disease that leads to destruction of insulin producing pancreatic Beta cells.

Individuals with type 1 diabetes requires life long insulin replacement with multiple daily insulin injection. daily,insulin pump therapy or the use of an automated insulin delivery system.

without insulin ,diabetic ketoacidosis develops and is life threatening.

In addition to insulin Therapy ,glucose monitoring with a continuous glucose monitor and a blood glucose monitor if continuous glucose monitor is unavailable is recommended .

Coenzyme Q10 supplementation has beneficial effects on glycemic control especially in diabetes , and 100-200 mg per day of Co Q10 could achieve the greatest benefit which could provide a basis for the dietary guidelines of Co Q10 in patients with glycemic disorders .

Co Q10 with a known antiinflammatory and antioxidant has beneficial effects on endothelial function and therefore minimize the microvascular and macrovascular complication in patients with type 1 diabetes mellitus.

Administration of Co Q10 for 3 months in type 1 diabetes mellitus in pediatric patients was will tolerated but had no favorable effect on endothelial dysfunction or metabolic parameters .

Co Q10 in addition to improving the metabolic hyperglycemia , it improve Hb A1c and the lipid profile.

patients with type 1 diabetes , especially poorly controlled had elevation of plasma vitamin E and coenzyme Q10 levels and decreased platelet redox status of coenzyme Q10 which may be an indicator of increased oxidative stress ,so Co Q10 has an antioxidant effects.

Researches on this topic are limited on pediatrics and investigators search for it and will see the result.(clinical trial)

Co Q10 is present in the forms of soft gel capsules ,oral spray , hard gel capsules and tablets .

Co Q10 approved from age of 2 years old to 18 years old .

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients diagnosed as type 1 diabetes mellitus from age of 2 years old to 18 years old with diabetes mellitus of duration at least 1 year.

Exclusion Criteria:

  • - patients diagnosed as diabetes mellitus less than 2 years old .
  • patients with diabetes mellitus of duration less than 1 year.
  • patients diagnosed as type 1 diabetes mellitus with Thyroid or celiac diseases.
  • other types of hyperglycemia rather than Type 1 diabetes mellitus.

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Will take Coenzyme Q10 soft gel capsules or tablets in a dose of 100-200mg of natural factors
Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets
Group A will take Soft gel capsules or tablets of Coenzyme Q10 in a dose of 100-200mg of natural factors or kirkman but group B will not take Coenzyme Q10 just observe them
Other Names:
  • Natural factors capsules or Kirkman tablets
Experimental: Group B
Will not take Coenzyme Q10 soft gel capsules or tablets
Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets
Group A will take Soft gel capsules or tablets of Coenzyme Q10 in a dose of 100-200mg of natural factors or kirkman but group B will not take Coenzyme Q10 just observe them
Other Names:
  • Natural factors capsules or Kirkman tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus
Time Frame: One year
This prospective randomized clinical trial will be conducted on 100 participants . Half of them will not receive treatment but group A will receive 100-200mg of Coenzyme Q10 . the level of glycated hemoglobin, fasting blood glucose will be assessed for both groups at baseline and after 3 months of treatment for ongoing use in diabetic children
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus .
Time Frame: One year
By ensuring of regular intake of Coenzyme Q10 capsules or tablets then assessment of glycated hemoglobin
One year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Christina Saad Abdel Malak Abdel Nour, Study producer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

October 30, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Coenzyme Q10 on diabetic child

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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