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

NCT01103817 | Completed Phase 2

• 1 other identifier: 1000014567
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes; Adolescents and Young Adults; Vitamin D; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 3 or 6 months

Secondary Outcomes (4)

• Monitoring of Vitamin D Levels in Vitamin D deficient subjects

  2-3 months

• Monitoring of Calcium Creatine Ratio in Vitamin D deficient subjects

  2-3 months

• Comparison of Systemic Blood Pressure

  Baseline

• Comparison of Urinary Albumin/Creatinine Ratio

  Baseline

Study Arms (2)

Vitamin D Sufficient

NO INTERVENTION

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

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

Interventions

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.

Also known as: Ddrops®

Vitamin D Deficient

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Cardiovascular Diseases

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Farid Mahmud, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

CA (1)