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Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes

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ClinicalTrials.gov Identifier: NCT02019186
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Robert Hoffman, Nationwide Children's Hospital

Brief Summary:
The endothelium is the lining of the blood vessels that helps prevent damage to the vessels. The endothelium does not function as well as it should in adolescents with type 1 diabetes. This causes future diabetes complications. Adolescents with diabetes also have abnormalities of the cells that repair the endothelium. These abnormalities may be due to damage caused by intermittent hyperglycemia. This studied is designed to study whether low dose, combined Vitamin C and E supplementation improves endothelial function and repair in adolescents with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Dietary Supplement: Vitamin C Dietary Supplement: Vitamin E Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
Study Start Date : December 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitamin C and E
6 weeks of daily treatment with Vitamin C and E
Dietary Supplement: Vitamin C
<30 kg 250 mg 30-60 kg 500 mg >60 kg 750 mg

Dietary Supplement: Vitamin E
<30 kg 100 IU, 30-60 kg 200 IU, >60 kg 300 IU




Primary Outcome Measures :
  1. endothelial function [ Time Frame: 6 weeks ]
    Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E


Secondary Outcome Measures :
  1. Endothelial progenitor cells [ Time Frame: 6 weeks ]
    Endothelial progenitor cells will be measured before and after 6 weeks of Vitamin C and E therapy



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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children and adolescent with T1D between 8 and 15 years of age will be studied.
  2. Started on insulin therapy immediately after diagnosis.
  3. Fasting c-peptide levels must be less than 0.4 ng/ml.
  4. Hgb A1c levels greater than 8.3%.
  5. All subjects must be in good health other than having diabetes. Subjects with hypothyroidism will be allowed assuming they are on stable thyroxine replacement and have normal thyroid function tests.
  6. Females on oral contraceptives will also be eligible to participate.

Exclusion Criteria:

  1. History oral hypoglycemic agent use.
  2. BMI>95th percentile
  3. Hypertension
  4. Elevated creatinine levels
  5. Microalbuminuria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019186


Locations
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United States, Ohio
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital

Publications:
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Responsible Party: Robert Hoffman, Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02019186     History of Changes
Other Study ID Numbers: CCRI-VITCE
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015
Keywords provided by Robert Hoffman, Nationwide Children's Hospital:
type 1 diabetes
endothelial function
adolescents
vitamin C
vitamin E
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vitamins
Ascorbic Acid
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents