A Phase 2 interventional study of Vitamin D in Diabetes Mellitus, Type 1, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment
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.
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.
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This study's enrollment of 33 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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.
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.
Also known as: Ddrops®
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.
Time frame: Baseline
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.
Time frame: Baseline, 3 or 6 months
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.
Time frame: 2-3 months
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.
Time frame: 2-3 months
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).
Time frame: Baseline
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).
Time frame: Baseline
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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