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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01103817
First received: April 13, 2010
Last updated: April 14, 2010
Last verified: April 2010

April 13, 2010
April 14, 2010
March 2010
January 2011   (final data collection date for primary outcome measure)
  • 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.

Same as current
Complete list of historical versions of study NCT01103817 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
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®
  • 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.

  • 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.

    Intervention: Dietary Supplement: Vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
No
Contact: Farid Mahmud, MD 416-813-8159 farid.mahmud@sickkids.ca
Canada
 
NCT01103817
1000014567
No
Dr. Farid Mahmud/ Principal Investigator, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Farid Mahmud, MD The Hospital for Sick Children
The Hospital for Sick Children
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP