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Completed

NCT Number: NCT01103817

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

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 names: Ddrops®

Primary outcomes

  1. Comparison of Endothelial Function

    Time frame: Baseline

    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.

  2. Change in Endothelial Function after Treatment with Vitamin D

    Time frame: Baseline, 3 or 6 months

    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 outcomes

  1. Monitoring of Vitamin D Levels in Vitamin D deficient subjects

    Time frame: 2-3 months

    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. Monitoring of Calcium Creatine Ratio in Vitamin D deficient subjects

    Time frame: 2-3 months

    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.

  3. Comparison of Systemic Blood Pressure

    Time frame: Baseline

    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).

  4. Comparison of Urinary Albumin/Creatinine Ratio

    Time frame: Baseline

    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).

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2010
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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