Type 1 Diabetes MellitusPhase 4NCT02019186
Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
A Phase 4 study testing Vitamin C and Vitamin E in people with Type 1 Diabetes Mellitus, run by Nationwide Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Vitamin C and Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- History oral hypoglycemic agent use.
- BMI>95th percentile
- Hypertension
- Elevated creatinine levels
- Microalbuminuria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Vitamin C, Vitamin E
- Keywords
- type 1 diabetes, endothelial function, adolescents, vitamin C, vitamin E
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
<30 kg 250 mg 30-60 kg 500 mg >60 kg 750 mg
Vitamin EDietary supplement
<30 kg 100 IU, 30-60 kg 200 IU, >60 kg 300 IU
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C and E | Experimental | 6 weeks of daily treatment with Vitamin C and E Receives: Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E
Measured: 6 weeks
Secondary outcomes (1)
Endothelial progenitor cells
Endothelial progenitor cells will be measured before and after 6 weeks of Vitamin C and E therapy
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Hoffman, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019186
- Sponsor's protocol ID
- CCRI-VITCE
- Status last verified
- Feb 2015
- First submitted
- 18 Dec 2013
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22925199Dye 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.
PubMed 22701470Varvarovska 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.
PubMed 12505749
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
- ClinicalTrials.gov ID
- NCT02019186
- Acronym / sponsor ID
- CCRI-VITCE
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes, endothelial function, adolescents, vitamin C, vitamin E
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin C and E | Experimental | Dietary Supplement: Vitamin C, Dietary Supplement: Vitamin E6 weeks of daily treatment with Vitamin C and E |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- History oral hypoglycemic agent use.
- BMI>95th percentile
- Hypertension
- Elevated creatinine levels
- Microalbuminuria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C<30 kg 250 mg 30-60 kg 500 mg >60 kg 750 mg | Dietary supplement | Vitamin C and E |
| Vitamin E<30 kg 100 IU, 30-60 kg 200 IU, >60 kg 300 IU | Dietary supplement | Vitamin C and E |
Primary outcome
endothelial function
Time frame: 6 weeks
Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E
1 secondary outcome
Endothelial progenitor cells
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Background: PubMed 22925199Hoffman 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.
- Background: PubMed 22701470Dye 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.
- Background: PubMed 12505749Varvarovska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin C and Vitamin E in people with Type 1 Diabetes Mellitus, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019186, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015; AzTrials last refreshed its copy on 1 Nov 2026.