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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019186
• Other study ID #: CCRI-VITCE
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2013
• Last updated: February 2, 2015
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Dietary Supplement:
• Vitamin C
<30 kg 250 mg 30-60 kg 500 mg >60 kg 750 mg
• Vitamin E
<30 kg 100 IU, 30-60 kg 200 IU, >60 kg 300 IU

Locations

Country	Name	City	State
United States	Research Institute at Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dye AS, Huang H, Bauer JA, Hoffman RP. Hyperglycemia increases muscle blood flow and alters endothelial function in adolescents with type 1 diabetes. Exp Diabetes Res. 2012;2012:170380. doi: 10.1155/2012/170380. Epub 2012 Jun 3. — View Citation

Hoffman RP, Dye AS, Bauer JA. Ascorbic acid blocks hyperglycemic impairment of endothelial function in adolescents with type 1 diabetes. Pediatr Diabetes. 2012 Dec;13(8):607-10. doi: 10.1111/j.1399-5448.2012.00882.x. Epub 2012 Aug 28. — View Citation

Varvarovská J, Racek J, Stozický F, Soucek J, Trefil L, Pomahacová R. Parameters of oxidative stress in children with Type 1 diabetes mellitus and their relatives. J Diabetes Complications. 2003 Jan-Feb;17(1):7-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function	Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E	6 weeks	No
Secondary	Endothelial progenitor cells	Endothelial progenitor cells will be measured before and after 6 weeks of Vitamin C and E therapy	6 weeks	No