Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
NCT ID: NCT01103817
Last Updated: 2016-06-01
Study Results
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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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2010-03-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vitamin D Sufficient
Sufficient is defined as a 25 OH vitamin D level \>50 nmol/l measured at baseline. No clinical intervention will be assigned to this group.
Subjects will have fasting bloodwork done. Other study measurements to be taken include: height and weight, stage of puberty, blood pressure, vitamin D and calcium intake information, diabetes risk information, demographic information and spot urine sample.
We will also do a non-invasive test called a "PAT" or 'peripheral arterial tonometry' to look at the health of your blood vessels.
No interventions assigned to this group
Vitamin D Deficient
Deficient is defined as a 25 OH vitamin D level ≤ 37.5 nmol/l. This group will receive Vitamin D.
Subjects will have fasting bloodwork done. Other study measurements to be taken include: height and weight, stage of puberty, blood pressure, vitamin D and calcium intake information, diabetes risk information, demographic information and spot urine sample.
We will also do a non-invasive test called a "PAT" or 'peripheral arterial tonometry' to look at the health of your blood vessels.
Vitamin D
Dosing If the 25 OH Vitamin D level at Baseline/Screening is less than 20 nmol/L then the subject will receive 2000 IU daily.
If the 25 OH Vitamin D level at Baseline/Screening is between 20 and 37.5 nmol/L then the subject will receive 1000 IU daily.
Interventions
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Vitamin D
Dosing If the 25 OH Vitamin D level at Baseline/Screening is less than 20 nmol/L then the subject will receive 2000 IU daily.
If the 25 OH Vitamin D level at Baseline/Screening is between 20 and 37.5 nmol/L then the subject will receive 1000 IU daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with type 1 diabetes for at least 2 years
3. Between the ages of 12 and 18 years
Exclusion Criteria
2. Diagnosed with familial hypercholesterolemia
3. Active smoker
4. Receiving lipid lowering medications
5. Receiving anti hypertensive medication
6. Significant chronic medical illness, including granulomatous disease
7. History of hypertension
8. BMI \>95%tile
9. Known renal failure
10. HbA1c greater than 12% on two successive occasions
11. Known peripheral vascular disease
12. Known hypercalcemia
12 Years
18 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Farid Mahmud
Staff Physician
Principal Investigators
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Farid Mahmud, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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1000014567
Identifier Type: -
Identifier Source: org_study_id
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