Efficacy of Coenzyme Q10 Supplementation on Metabolic Control in Children With Type 1 Diabetes Mellitus: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 100
- Primary Endpoint
- Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus
Study Overview
Brief Summary
Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin
Detailed Description
Type 1 diabetes mellitus is an autoimmune disease that leads to destruction of insulin producing pancreatic Beta cells.
Individuals with type 1 diabetes requires life long insulin replacement with multiple daily insulin injection. daily,insulin pump therapy or the use of an automated insulin delivery system.
without insulin ,diabetic ketoacidosis develops and is life threatening.
In addition to insulin Therapy ,glucose monitoring with a continuous glucose monitor and a blood glucose monitor if continuous glucose monitor is unavailable is recommended .
Coenzyme Q10 supplementation has beneficial effects on glycemic control especially in diabetes , and 100-200 mg per day of Co Q10 could achieve the greatest benefit which could provide a basis for the dietary guidelines of Co Q10 in patients with glycemic disorders .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients diagnosed as type 1 diabetes mellitus from age of 2 years old to 18 years old with diabetes mellitus of duration at least 1 year.
Exclusion Criteria
- •- patients diagnosed as diabetes mellitus less than 2 years old .
- •patients with diabetes mellitus of duration less than 1 year.
- •patients diagnosed as type 1 diabetes mellitus with Thyroid or celiac diseases.
- •other types of hyperglycemia rather than Type 1 diabetes mellitus.
Arms & Interventions
Group A
Will take Coenzyme Q10 soft gel capsules or tablets in a dose of 100-200mg of natural factors
Intervention: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets (Drug)
Group B
Will not take Coenzyme Q10 soft gel capsules or tablets
Intervention: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets (Drug)
Outcomes
Primary Outcomes
Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus
Time Frame: One year
This prospective randomized clinical trial will be conducted on 100 participants . Half of them will not receive treatment but group A will receive 100-200mg of Coenzyme Q10 . the level of glycated hemoglobin, fasting blood glucose will be assessed for both groups at baseline and after 3 months of treatment for ongoing use in diabetic children
Secondary Outcomes
- Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus .(One year)
Investigators
Christina Saad Abdel Malak Abdel Nour
Principal Investigator
Assiut University