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

Nationwide Children's Hospital logo

Nationwide Children's Hospital

Status and phase

Completed
Phase 4

Conditions

Type 1 Diabetes Mellitus

Treatments

Dietary Supplement: Vitamin C
Dietary Supplement: Vitamin E

Study type

Interventional

Funder types

Other

Identifiers

NCT02019186
CCRI-VITCE

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

8 to 15 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Vitamin C and E
Experimental group
Description:
6 weeks of daily treatment with Vitamin C and E
Treatment:
Dietary Supplement: Vitamin E
Dietary Supplement: Vitamin C

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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