NCT02019186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

December 18, 2013

Last Update Submit

February 2, 2015

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetesendothelial functionadolescentsvitamin Cvitamin E

Outcome Measures

Primary Outcomes (1)

  • endothelial function

    Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E

    6 weeks

Secondary Outcomes (1)

  • Endothelial progenitor cells

    6 weeks

Study Arms (1)

Vitamin C and E

EXPERIMENTAL

6 weeks of daily treatment with Vitamin C and E

Dietary Supplement: Vitamin CDietary Supplement: Vitamin E

Interventions

Vitamin CDIETARY_SUPPLEMENT

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

Vitamin C and E
Vitamin EDIETARY_SUPPLEMENT

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

Vitamin C and E

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescent with T1D between 8 and 15 years of age will be studied.
  • Started on insulin therapy immediately after diagnosis.
  • Fasting c-peptide levels must be less than 0.4 ng/ml.
  • Hgb A1c levels greater than 8.3%.
  • 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.
  • Females on oral contraceptives will also be eligible to participate.

You may not qualify if:

  • History oral hypoglycemic agent use.
  • BMI\>95th percentile
  • Hypertension
  • Elevated creatinine levels
  • Microalbuminuria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (3)

  • 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.

    PMID: 22925199BACKGROUND

  • 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.

    PMID: 22701470BACKGROUND

  • Varvarovska J, Racek J, Stozicky F, Soucek J, Trefil L, Pomahacova 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. doi: 10.1016/s1056-8727(01)00228-8.

    PMID: 12505749BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Ascorbic AcidVitamin E

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 24, 2013

Study Start

December 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations

US(1)