Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Dietary Supplement: Coenzyme Q10; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03111433

PHCL136

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Group I

Experimental group

Description:

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

Treatment:

Dietary Supplement: Coenzyme Q10

Drug: Insulin

Group II

Active Comparator group

Description:

this group of patients will receive their standard insulin treatment only

Treatment:

Drug: Insulin