Vitamin D DeficiencyNCT00736632
Vitamin D, Insulin Resistance, and Cardiovascular Disease
A study testing Vitamin D3 in people with Vitamin D Deficiency and Insulin Resistance, run by Washington University School of Medicine at 1 site in United States.
Trial summary
In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Vitamin D Deficiency, Insulin Resistance, Type 2 Diabetes Mellitus
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to 13 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- 25 (OH) vitamin D levels < 25 ng/ml
- Age 25 to 80 years
- Not on insulin for diabetes treatment
- HbA1c 5.5% -9.5%
- Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications
Who cannot join
- Pregnancy
- Patients with systolic >160 or diastolic >100 mmHg
- High urine calcium or history of recurrent kidney stones
- Cardiovascular disease
- Stage 3 or worse chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes
Read the detailed description
This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and at the end of the study.
- Conditions
- Vitamin D Deficiency, Insulin Resistance, Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D, Insulin Resistance, Type 2 Diabetes Mellitus, Cardiovascular Disease
- Medical subject headings
- Vitamin D Deficiency, Insulin Resistance, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Vitamin D
Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
PlaceboDrug
Placebo pill orally daily Calcium carbonate 500 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily. Receives: Drug: Placebo |
| Vitamin D | Active comparator | Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily. Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.
Measured: 0, 2, and 4 months
Secondary outcomes (8)
Brachial Artery Reactivity Testing
Brachial artery response to hyperemia assessed by measuring brachial artery diameter every 30 seconds for 180 seconds after a 5-minute occlusion with arm cuff above systolic blood pressure, with response defined as maximal percentage increase above baseline.
Measured: 0, 2, and 4 months
Macrophage Cholesterol Metabolism
Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.
Measured: 0 and 4 months
Serum Calcium
Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA
Measured: 0, 2, and 4 Month
HbA1C
HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood
Measured: 0, 2, and 4 month
Vitamin D
25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry
Measured: 0, 2, and 4 Month
hsCRP
High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay
Measured: 0, 2, and 4 Month
Fasting Glucose
Serum fasting glucose assessed by hexokinase method
Measured: 0, 2, and 4 Month
Urine Calcium to Creatinine Ratio.
Urine calcium to creatinine ratio assessed by spectrophotometry
Measured: 0, 2 and 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startMay 2006
- Primary completion13 Jan 2019
- Study completion13 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Carlos Bernal-MIzrachi, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736632
- Sponsor's protocol ID
- 201103002
- Other IDs
- R01HL094818
- Status last verified
- Jan 2020
- First submitted
- 15 Aug 2008
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D, Insulin Resistance, and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00736632
- Acronym / sponsor ID
- 201103002
- Conditions
- Vitamin D Deficiency, Insulin Resistance, Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension
- Keywords
- Vitamin D, Insulin Resistance, Type 2 Diabetes Mellitus, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Diabetes Association
- Study start
- May 2006
- Primary completion
- 13 Jan 2019 (actual)
- Study completion
- 13 Jan 2019 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes
Detailed description
This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily. |
| Vitamin D | Active comparator | Drug: Vitamin D3Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes
- 25 (OH) vitamin D levels < 25 ng/ml
- Age 25 to 80 years
- Not on insulin for diabetes treatment
- HbA1c 5.5% -9.5%
Key exclusion criteria (5 listed)
- Pregnancy
- Patients with systolic >160 or diastolic >100 mmHg
- High urine calcium or history of recurrent kidney stones
- Cardiovascular disease
- Stage 3 or worse chronic kidney disease
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 D3Also: Vitamin DCholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily | Drug | Vitamin D |
| PlaceboPlacebo pill orally daily Calcium carbonate 500 mg twice daily | Drug | Placebo |
Primary outcome
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
Time frame: 0, 2, and 4 months
24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.
8 secondary outcomes
Brachial Artery Reactivity Testing
Time frame: 0, 2, and 4 months
Macrophage Cholesterol Metabolism
Time frame: 0 and 4 months
Serum Calcium
Time frame: 0, 2, and 4 Month
HbA1C
Time frame: 0, 2, and 4 month
Vitamin D
Time frame: 0, 2, and 4 Month
hsCRP
Time frame: 0, 2, and 4 Month
Fasting Glucose
Time frame: 0, 2, and 4 Month
Urine Calcium to Creatinine Ratio.
Time frame: 0, 2 and 4 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Washington University Endocrinology Department websiteLink provided by the sponsor.
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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.
Carlos Bernal-MIzrachi, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Vitamin D Deficiency and Insulin Resistance, run by Washington University School of Medicine at 1 site in United States.
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 6 inclusion and 5 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 10 Feb 2020. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP) (time frame: 0, 2, and 4 months). 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 10 Feb 2020.