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Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 Diabetes, Adolescents and Young Adults, Vitamin D, Cardiovascular Disease

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with type 1 diabetes, according to Canadian Diabetes Association guidelines
  2. Diagnosed with type 1 diabetes for at least 2 years
  3. Between the ages of 12 and 18 years

Exclusion Criteria:

  1. Previous organ transplantation
  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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Vitamin D Sufficient

Vitamin D Deficient

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Comparison of Endothelial Function
We will compare endothelial function in adolescents with type 1 diabetes divided into 2 groups on the basis of vitamin D status (deficient and sufficient). Endothelial function will be assessed by peripheral arterial tonometry (PAT) which measures the elasticity of the arteries.
Change in Endothelial Function after Treatment with Vitamin D
We will measure the change in endothelial function from baseline in the children that were vitamin D deficient. This measurement will be done once the child has become vitamin D sufficient. Vitamin D status will be assessed at 3 months. If the levels remain deficient treatment would continue for another 3 months, with repeat testing at 6 months. Endothelial function will be assessed by peripheral arterial tonometry (PAT) which measures the elasticity of the arteries.

Secondary Outcome Measures

Monitoring of Vitamin D Levels in Vitamin D deficient subjects
At a vist to take place at 2-3 months, the Vitamin D deficient sujects will undergo blood sampling for 25 hydroxyvitamin D levels to ensure appropriate treatment with D Drops to normalize 25 OH vitamin D levels greater than 50 nmol/L.
Monitoring of Calcium Creatine Ratio in Vitamin D deficient subjects
At a vist to take place at 2-3 months, the Vitamin D deficient sujects will have a urine assessment of spot calcium creatinine ratio to ensure that hypercalcemia (calcium/ creatinine ratio greater than 0.7) is not present.
Comparison of Systemic Blood Pressure
We will compare endothelial function in adolescents with type 1 diabetes divided into 2 groups on the basis of vitamin D status (deficient and sufficient).
Comparison of Urinary Albumin/Creatinine Ratio
We will compare the urinary albumin/creatinine ratio in adolescents with type 1 diabetes divided into 2 groups on the basis of vitamin D status (deficient and sufficient).

Full Information

First Posted
April 13, 2010
Last Updated
May 30, 2016
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01103817
Brief Title
Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
Official Title
Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to study the role of low vitamin D levels on the health of blood vessels or vascular function in adolescents and young adults with type 1 diabetes.
Detailed Description
Vitamin D deficiency is known to be common in patients with type 1 diabetes. Studies in adults have shown that vitamin D deficiency is associated with cardiovascular events such as stroke, myocardial infarction and peripheral arterial disease. However, the impact of this deficiency on vascular health in adolescents with diabetes has not been examined. Furthermore given that endothelial dysfunction is reversible, early detection of this process may have therapeutic and prognostic implications in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Type 1 Diabetes, Adolescents and Young Adults, Vitamin D, Cardiovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D Sufficient
Arm Type
No Intervention
Arm Description
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.
Arm Title
Vitamin D Deficient
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Ddrops®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of Endothelial Function
Description
We will compare endothelial function in adolescents with type 1 diabetes divided into 2 groups on the basis of vitamin D status (deficient and sufficient). Endothelial function will be assessed by peripheral arterial tonometry (PAT) which measures the elasticity of the arteries.
Time Frame
Baseline
Title
Change in Endothelial Function after Treatment with Vitamin D
Description
We will measure the change in endothelial function from baseline in the children that were vitamin D deficient. This measurement will be done once the child has become vitamin D sufficient. Vitamin D status will be assessed at 3 months. If the levels remain deficient treatment would continue for another 3 months, with repeat testing at 6 months. Endothelial function will be assessed by peripheral arterial tonometry (PAT) which measures the elasticity of the arteries.
Time Frame
Baseline, 3 or 6 months
Secondary Outcome Measure Information:
Title
Monitoring of Vitamin D Levels in Vitamin D deficient subjects
Description
At a vist to take place at 2-3 months, the Vitamin D deficient sujects will undergo blood sampling for 25 hydroxyvitamin D levels to ensure appropriate treatment with D Drops to normalize 25 OH vitamin D levels greater than 50 nmol/L.
Time Frame
2-3 months
Title
Monitoring of Calcium Creatine Ratio in Vitamin D deficient subjects
Description
At a vist to take place at 2-3 months, the Vitamin D deficient sujects will have a urine assessment of spot calcium creatinine ratio to ensure that hypercalcemia (calcium/ creatinine ratio greater than 0.7) is not present.
Time Frame
2-3 months
Title
Comparison of Systemic Blood Pressure
Description
We will compare endothelial function in adolescents with type 1 diabetes divided into 2 groups on the basis of vitamin D status (deficient and sufficient).
Time Frame
Baseline
Title
Comparison of Urinary Albumin/Creatinine Ratio
Description
We will compare the urinary albumin/creatinine ratio in adolescents with type 1 diabetes divided into 2 groups on the basis of vitamin D status (deficient and sufficient).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with type 1 diabetes, according to Canadian Diabetes Association guidelines Diagnosed with type 1 diabetes for at least 2 years Between the ages of 12 and 18 years Exclusion Criteria: Previous organ transplantation Diagnosed with familial hypercholesterolemia Active smoker Receiving lipid lowering medications Receiving anti hypertensive medication Significant chronic medical illness, including granulomatous disease History of hypertension BMI >95%tile Known renal failure HbA1c greater than 12% on two successive occasions Known peripheral vascular disease Known hypercalcemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farid Mahmud, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes

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