Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 |
Dietary Supplement: Vitamin D |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes |
- Comparison of Endothelial Function [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 3 or 6 months ] [ Designated as safety issue: No ]
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.
- Monitoring of Vitamin D Levels in Vitamin D deficient subjects [ Time Frame: 2-3 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: 2-3 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 62 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 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. |
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|
Experimental: 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. |
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. Other Name: Ddrops®
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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.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Farid Mahmud, MD | 416-813-8159 | farid.mahmud@sickkids.ca |
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Farid Mahmud, MD | |
| Contact: Jonathan Yeshayahu, MD 416-813-8088 jonathan.yeshayahu@sickkids.ca | |
| Principal Investigator: Farid Mahmud, MD | |
| Sub-Investigator: Jonathan Yeshayahu, MD | |
| Sub-Investigator: Etienne Sochett, MD | |
| Principal Investigator: | Farid Mahmud, MD | The Hospital for Sick Children |
More Information
No publications provided
| Responsible Party: | Dr. Farid Mahmud/ Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT01103817 History of Changes |
| Other Study ID Numbers: | 1000014567 |
| Study First Received: | April 13, 2010 |
| Last Updated: | April 14, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
Type 1 Diabetes Adolescents and Young Adults Vitamin D Cardiovascular Disease |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Vitamin D |
Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013