Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus

NCT03111433 | Completed Phase 2

• 1 other identifier: PHCL136
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes mellitus; Coenzyme Q10; endothelial dysfunction; pediatric patients

Outcome Measures

Primary Outcomes (1)

• change in soluble interacellular adhesion molecule level

  it will be assessed at baseline and after three months of treatment

  three months

Study Arms (2)

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

Coenzyme Q10 DIETARY_SUPPLEMENT

Coenzyme Q10 soft gelatin capsule 100mg

Group I

Insulin DRUG

multiple dose insulin injection therapy

Group I; Group II

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams university pediatric's hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

coenzyme Q10; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant in clinical pharmacy department ,faculty of pharmacy , Ainshams university

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 12, 2017
• Study Start: March 19, 2017
• Primary Completion: January 20, 2018
• Study Completion: January 20, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-04

Locations

EG (1)