Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

NCT ID: NCT03111433

Last Updated: 2018-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-19

Study Completion Date

2018-01-20

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Coenzyme Q10

Intervention Type DIETARY_SUPPLEMENT

Coenzyme Q10 soft gelatin capsule 100mg

Insulin

Intervention Type DRUG

multiple dose insulin injection therapy

Group II

this group of patients will receive their standard insulin treatment only

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

multiple dose insulin injection therapy

Interventions

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Coenzyme Q10

Coenzyme Q10 soft gelatin capsule 100mg

Intervention Type DIETARY_SUPPLEMENT

Insulin

multiple dose insulin injection therapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Heba ibrahim Mohamed serag

teaching assistant in clinical pharmacy department ,faculty of pharmacy , Ainshams university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ainshams university pediatric's hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PHCL136

Identifier Type: -

Identifier Source: org_study_id

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