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NCT Number: NCT02019186

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescent with T1D between 8 and 15 years of age will be studied.
  • Started on insulin therapy immediately after diagnosis.
  • Fasting c-peptide levels must be less than 0.4 ng/ml.
  • Hgb A1c levels greater than 8.3%.
  • 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.
  • Females on oral contraceptives will also be eligible to participate.

Exclusion criteria

  • History oral hypoglycemic agent use.
  • BMI>95th percentile
  • Hypertension
  • Elevated creatinine levels
  • Microalbuminuria.

Treatment and study plan

Vitamin C

Dietary Supplement

<30 kg 250 mg 30-60 kg 500 mg >60 kg 750 mg

Vitamin E

Dietary Supplement

<30 kg 100 IU, 30-60 kg 200 IU, >60 kg 300 IU

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2013
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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