Diabetes Mellitus, Type 1Phase 2NCT01103817
Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
A Phase 2 study testing Vitamin D in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Previous organ transplantation
- Diagnosed with familial hypercholesterolemia
- Active smoker
- Receiving lipid lowering medications
- Receiving anti hypertensive medication
- Significant chronic medical illness, including granulomatous disease
Show all 12Show fewer
- History of hypertension
- BMI >95%tile
- Known renal failure
- HbA1c greater than 12% on two successive occasions
- Known peripheral vascular disease
- Known hypercalcemia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Vitamin D
- Keywords
- Type 1 Diabetes, Adolescents and Young Adults, Vitamin D, Cardiovascular Disease
- Medical subject headings
- Diabetes Mellitus, Type 1, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Ddrops®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 or 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farid Mahmud, The Hospital for Sick Children
- Investigators
- Farid Mahmud, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103817
- Sponsor's protocol ID
- 1000014567
- Status last verified
- May 2016
- First submitted
- 13 Apr 2010
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01103817
- Acronym / sponsor ID
- 1000014567
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes, Adolescents and Young Adults, Vitamin D, Cardiovascular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Vitamin DDeficient 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Previous organ transplantation
- Diagnosed with familial hypercholesterolemia
- Active smoker
- Receiving lipid lowering medications
- Receiving anti hypertensive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Ddrops®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. | Dietary supplement | Vitamin D Deficient |
Primary outcome
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.
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.
4 secondary outcomes
Monitoring of Vitamin D Levels in Vitamin D deficient subjects
Time frame: 2-3 months
Monitoring of Calcium Creatine Ratio in Vitamin D deficient subjects
Time frame: 2-3 months
Comparison of Systemic Blood Pressure
Time frame: Baseline
Comparison of Urinary Albumin/Creatinine Ratio
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farid Mahmud, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Endothelial Function (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.