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

February 2, 2015 updated by: Robert Hoffman, Nationwide Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Research Institute at Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCRI-VITCE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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