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

The Hospital for Sick Children

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01103817

1000014567

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Vitamin D Sufficient

No Intervention group

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.

Vitamin D Deficient

Experimental group

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.

Treatment:

Dietary Supplement: Vitamin D