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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02019186

Enrollment

Registered

2013-12-24

Start date

2013-12-31

Completion date

2015-01-31

Last updated

2015-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes, endothelial function, adolescents, vitamin C, vitamin E

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.

Interventions

DIETARY_SUPPLEMENTVitamin C

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

DIETARY_SUPPLEMENTVitamin E

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 15 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
endothelial function	6 weeks	Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E

Secondary

Measure	Time frame	Description
Endothelial progenitor cells	6 weeks	Endothelial progenitor cells will be measured before and after 6 weeks of Vitamin C and E therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026