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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103817
• Other study ID #: 1000014567
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2010
• Last updated: May 30, 2016
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: May 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline	No
Primary	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.	Baseline, 3 or 6 months	No
Secondary	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.	2-3 months	Yes
Secondary	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.	2-3 months	Yes
Secondary	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).	Baseline	No
Secondary	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).	Baseline	No