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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin C and E

6 weeks of daily treatment with Vitamin C and E

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

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

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin C

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

Intervention Type DIETARY_SUPPLEMENT

Vitamin E

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.