Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabet... | NCT03111433

Studies
Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

NCT03111433

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Apr 3, 2018Actual

Enrollment

49Actual

Phase

Phase 2

Conditions

Diabetes Mellitus, Type 1

Interventions

Coenzyme Q10
Insulin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2017Actual

Primary Completion Date

Jan 20, 2018Actual

Completion Date

Jan 20, 2018Actual

First Submitted Date

Apr 3, 2017

First Submission Date that Met QC Criteria

Apr 7, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2018

Last Update Posted Date

Apr 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Heba ibrahim Mohamed serag, teaching assistant in clinical pharmacy department ,faculty of pharmacy , Ainshams university, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I	Experimental	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	Dietary Supplement: Coenzyme Q10 Drug: Insulin
Group II	Active Comparator	this group of patients will receive their standard insulin treatment only	Drug: Insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coenzyme Q10	Dietary Supplement	Coenzyme Q10 soft gelatin capsule 100mg	Group I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in soluble interacellular adhesion molecule level	it will be assessed at baseline and after three months of treatment	three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: patients from 8 to 18 years old.
Outpatient with at least 1 year history of type 1 diabetes mellitus.
Insulin requirement of more than or equal 0.5 U/Kg/day.
Approval to participate and give informed consent.

Exclusion Criteria:

Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
Preexisting cardiovascular disease or hypertension.
Chronic kidney disease or chronic liver disease.
Significant mental illness.
Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
Intake of coenzyme Q10 within the last 3 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ainshams university pediatric's hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C024989	coenzyme Q10
D007328	Insulin

Ancestor Terms

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided