Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111433
• Other study ID #: PHCL136
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2017
• Last updated: April 1, 2018
• Start date: March 19, 2017
• Est. completion date: January 20, 2018

Study information

• Verified date: April 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 20, 2018
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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 a-tocopherol and omega3 supplement within the last 3 months.

6. Intake of coenzyme Q10 within the last 3 months.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Dietary Supplement:
• Coenzyme Q10
Coenzyme Q10 soft gelatin capsule 100mg

Drug:
• Insulin
multiple dose insulin injection therapy

Locations

Country	Name	City	State
Egypt	Ainshams university pediatric's hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in soluble interacellular adhesion molecule level	it will be assessed at baseline and after three months of treatment	three months