Vitamin D DeficiencyNCT01655810
Vitamin D, Cardiovascular Disease, and African Americans
A study testing Vitamin D3 and Calcium carbonate in people with Vitamin D Deficiency and Type 2 Diabetes Mellitus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Vitamin D Deficiency, Type 2 Diabetes Mellitus, Cardiovascular Disease
- What is being tested?
- Vitamin D3 and Calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2012to 9 Feb 2018
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African Americans of both genders
- Age 50-70 years
- Type 2 diabetes (A1C < 9.0%), on stable therapy with oral medications, insulin, or a combination
- 25(OH)D level < 20 ng/ml
- BP < 140/90 mmHg; LDL < 140 mg/dl
Who cannot join
- Pregnancy
- Cardiovascular disease
- Stage 3 or worse chronic kidney disease
- High urine or serum calcium or history of recurrent kidney stones
- Unstable medical conditions or major systemic diseases such as malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D and Early Markers of Cardiovascular Disease in African Americans
African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.
Read the detailed description
This study will be a double blinded, randomized controlled trial of vitamin D3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.
- Being tested
- Vitamin D3, Calcium carbonate
- Medical subject headings
- Vitamin D Deficiency, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Multivitamin containing cholecalciferol 4000 units orally daily
Vitamin D3Dietary supplement
Also called Cholecalciferol
Multivitamin containing cholecalciferol 600 units orally daily
Calcium carbonateDietary supplement
500 mg orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D 4000 IU | Active comparator | PO daily Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate |
| Vitamin D 600 IU | Active comparator | PO daily Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in carotid intima-medial thickness
Measured: 0, 6, and 12 months
Secondary outcomes (3)
Change from baseline in systemic inflammatory markers
Measured: 0, 6, and 12 months
Serum calcium
Measured: 0, 1, 3, 6, 9, and 12 months
Urinary Calcium
Measured: 0, 1, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study start13 Aug 2012
- Primary completion9 Feb 2018
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Carlos Bernal-Mizrachi, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655810
- Sponsor's protocol ID
- 201102160
- Status last verified
- Jun 2020
- First submitted
- 19 Jul 2012
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Early Markers of Cardiovascular Disease in African Americans
- ClinicalTrials.gov ID
- NCT01655810
- Acronym / sponsor ID
- 201102160
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 13 Aug 2012 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 2 Aug 2012 (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.
African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.
Detailed description
This study will be a double blinded, randomized controlled trial of vitamin D3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.
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 |
|---|---|---|
| Vitamin D 4000 IU | Active comparator | Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonatePO daily |
| Vitamin D 600 IU | Active comparator | Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonatePO daily |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- African Americans of both genders
- Age 50-70 years
- Type 2 diabetes (A1C < 9.0%), on stable therapy with oral medications, insulin, or a combination
- 25(OH)D level < 20 ng/ml
- BP < 140/90 mmHg; LDL < 140 mg/dl
Key exclusion criteria (5 listed)
- Pregnancy
- Cardiovascular disease
- Stage 3 or worse chronic kidney disease
- High urine or serum calcium or history of recurrent kidney stones
- Unstable medical conditions or major systemic diseases such as malignancy
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: CholecalciferolMultivitamin containing cholecalciferol 4000 units orally daily | Dietary supplement | Vitamin D 4000 IU |
| Vitamin D3Also: CholecalciferolMultivitamin containing cholecalciferol 600 units orally daily | Dietary supplement | Vitamin D 600 IU |
| Calcium carbonate500 mg orally twice daily | Dietary supplement | Vitamin D 4000 IU, Vitamin D 600 IU |
Primary outcome
Change from baseline in carotid intima-medial thickness
Time frame: 0, 6, and 12 months
3 secondary outcomes
Change from baseline in systemic inflammatory markers
Time frame: 0, 6, and 12 months
Serum calcium
Time frame: 0, 1, 3, 6, 9, and 12 months
Urinary Calcium
Time frame: 0, 1, 3, 6, 9, and 12 months
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 5 Jun 2020.
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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, MD 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 and Calcium carbonate in people with Vitamin D Deficiency and Type 2 Diabetes Mellitus, 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 5 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 5 Jun 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. 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?
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?
Change from baseline in carotid intima-medial thickness (time frame: 0, 6, and 12 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 5 Jun 2020.