Effect of Coenzyme Q10 on Diabetic Children

NCT06361680 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Coenzyme Q10 on diabetic child
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus

  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 Outcomes (1)

• Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus .

  One year

Study Arms (2)

Group A

EXPERIMENTAL

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 B

EXPERIMENTAL

Will not take Coenzyme Q10 soft gel capsules or tablets

Drug: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets

Interventions

Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets DRUG

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

Also known as: Natural factors capsules or Kirkman tablets

Group A; Group B

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Serag H, El Wakeel L, Adly A. Coenzyme Q10 administration has no effect on sICAM-1 and metabolic parameters of pediatrics with type 1 diabetes mellitus. Int J Vitam Nutr Res. 2021 Jun;91(3-4):315-324. doi: 10.1024/0300-9831/a000636. Epub 2020 Jan 16.

  PMID: 31942840 BACKGROUND

• Sangouni AA, Taghdir M, Mirahmadi J, Sepandi M, Parastouei K. Effects of curcumin and/or coenzyme Q10 supplementation on metabolic control in subjects with metabolic syndrome: a randomized clinical trial. Nutr J. 2022 Oct 3;21(1):62. doi: 10.1186/s12937-022-00816-7.

  PMID: 36192751 BACKGROUND

• Liang Y, Zhao D, Ji Q, Liu M, Dai S, Hou S, Liu Z, Mao Y, Tian Z, Yang Y. Effects of coenzyme Q10 supplementation on glycemic control: A GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials. EClinicalMedicine. 2022 Aug 3;52:101602. doi: 10.1016/j.eclinm.2022.101602. eCollection 2022 Oct.

  PMID: 35958521 BACKGROUND

• Stojanovic M, Radenkovic M. A meta-analysis of randomized and placebo-controlled clinical trials suggests that coenzyme Q10 at low dose improves glucose and HbA1c levels. Nutr Res. 2017 Feb;38:1-12. doi: 10.1016/j.nutres.2016.12.001. Epub 2016 Dec 8.

  PMID: 28381349 BACKGROUND

• Salardi S, Zucchini S, Elleri D, Grossi G, Bargossi AM, Gualandi S, Santoni R, Cicognani A, Cacciari E. High glucose levels induce an increase in membrane antioxidants, in terms of vitamin E and coenzyme Q10, in children and adolescents with type 1 diabetes. Diabetes Care. 2004 Feb;27(2):630-1. doi: 10.2337/diacare.27.2.630. No abstract available.

  PMID: 14747266 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christina Saad Abdel Malak Abdel Nour

  Study producer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faisal Alkhateeb Ahmad Abdullah, Professor

CONTACT

01003858676; faisalalkhateeb@aun.edu.eg

Christina Saad Abdel Malak Abdel Nour

CONTACT

01270624513; tinasaad071@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 12, 2024
• Study Start: October 30, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share