Vitamin D DeficiencyNCT01570309
Vitamin D Repletion in Coronary Artery Disease
A study testing Ergocalciferol and Sugar pill in people with Vitamin D Deficiency and Coronary Artery Disease, run by Seth I. Sokol, M.D. at 2 sites in United States.
Trial summary
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Coronary Artery Disease, Endothelial Dysfunction
- What is being tested?
- Ergocalciferol and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Mar 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and nonpregnant females greater than 18 years of age
- ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
- Serum 25-hydroxyvitamin D < 20 ng/ml
Who cannot join
- confinement to a nursing facility, institution or home
- GFR < 60 ml/min (by MDRD equation)
- presence of liver disease
- hypercalcemia
- NYHA class III or IV heart failure
- cardiogenic shock at time of presentation
Show all 15Show fewer
- current planned or emergent CABG
- prior gastric or small bowel surgery
- pancreatitis
- malabsorption
- inflammatory bowel disease
- autoimmune disease
- active malignancy
- current use of > 800 IU/day of vitamin D
- Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jacobi Medical Center
The Bronx, New York, 10461
Montefiore Medical Center / Weiler division
The Bronx, New York, 10461
About this study
Official title: The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.
The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.
Read the detailed description
100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules (s-VCAM, s-ICAM, soluble e-selectin). Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway (IL-12, IFN-g and CXCL-10 - "IFN-g axis") the investigators have linked to coronary atherogenesis (independent of CRP) and poor CV outcomes, will be measured over the 12 week study period. Given published evidence showing that Vit D can influence this T- cell pathway, specific aim 2 will add mechanistic insights to this proposal. High sensitivity C-reactive protein (hs-CRP) will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status.
- Being tested
- Ergocalciferol, Sugar pill
- Keywords
- vitamin D,, vitamin D deficiency, coronary artery disease, ergocalciferol, endothelial function, adhesion molecules, inflammation, IL-12, interferon-gamma, CXCL-10, reactive hyperemia peripheral arterial tonometry, endothelial dysfunction, cytokines, chemokines
- Medical subject headings
- Vitamin D Deficiency, Coronary Artery Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
Oral capsule, 50,000 units, once a week, 12 weeks
Sugar pillOther
Oral capsule, once a week, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ergocalciferol | Active comparator | 50,000 units of ergocalciferol once a week for 12 weeks Receives: Drug: Ergocalciferol |
| Sugar pill | Placebo comparator | Not described Receives: Other: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.
Measured: Baseline and 12 weeks
Inflammation -
Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups
Measured: Baseline and 12 weeks
Inflammation
Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups
Measured: Baseline to 12 weeks
Inflammation
Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups
Measured: Baseline to 12 weeks
Inflammation
Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startAug 2008
- Primary completionMar 2011
- Study completionMar 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seth I. Sokol, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Jacobi Medical Center, Albert Einstein College of Medicine, Yale University, Montefiore Medical Center
- Responsible party
- Sponsor-investigator, Seth I. Sokol, M.D., New York City Health and Hospitals Corporation
- Investigators
- Seth I Sokol, MD, Principal investigator, Jacobi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570309
- Sponsor's protocol ID
- AHA Award #0885041N
- Status last verified
- Aug 2013
- First submitted
- 26 Mar 2012
- Last updated
- 10 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sokol SI, Srinivas V, Crandall JP, Kim M, Tellides G, Lebastchi AH, Yu Y, Gupta AK, Alderman MH. The effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease. Vasc Med. 2012 Dec;17(6):394-404. doi: 10.1177/1358863X12466709.
PubMed 23184900
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01570309
- Acronym / sponsor ID
- AHA Award #0885041N
- Keywords
- vitamin D,, vitamin D deficiency, coronary artery disease, ergocalciferol, endothelial function, adhesion molecules, inflammation, IL-12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Seth I. Sokol, M.D.University, hospital or other
- Collaborators
- American Heart Association, Jacobi Medical Center, Albert Einstein College of Medicine, Yale University, Montefiore Medical Center
- Study start
- Aug 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Posted 10 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.
The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.
Detailed description
100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules (s-VCAM, s-ICAM, soluble e-selectin). Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway (IL-12, IFN-g and CXCL-10 - "IFN-g axis") the investigators have linked to coronary atherogenesis (independent of CRP) and poor CV outcomes, will be measured over the 12 week study period. Given published evidence showing that Vit D can influence this T- cell pathway, specific aim 2 will add mechanistic insights to this proposal. High sensitivity C-reactive protein (hs-CRP) will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status.
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 |
|---|---|---|
| Ergocalciferol | Active comparator | Drug: Ergocalciferol50,000 units of ergocalciferol once a week for 12 weeks |
| Sugar pill | Placebo comparator | Other: Sugar pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and nonpregnant females greater than 18 years of age
- ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
- Serum 25-hydroxyvitamin D < 20 ng/ml
Key exclusion criteria (15 listed)
- confinement to a nursing facility, institution or home
- GFR < 60 ml/min (by MDRD equation)
- presence of liver disease
- hypercalcemia
- NYHA class III or IV heart failure
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 |
|---|---|---|
| ErgocalciferolOral capsule, 50,000 units, once a week, 12 weeks | Drug | Ergocalciferol |
| Sugar pillOral capsule, once a week, 12 weeks | Other | Sugar pill |
Primary outcome
Endothelial Function
Time frame: Baseline and 12 weeks
Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.
Inflammation -
Time frame: Baseline and 12 weeks
Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups
Inflammation
Time frame: Baseline to 12 weeks
Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups
Inflammation
Time frame: Baseline to 12 weeks
Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups
Inflammation
Time frame: Baseline to week 12
Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23184900Sokol SI, Srinivas V, Crandall JP, Kim M, Tellides G, Lebastchi AH, Yu Y, Gupta AK, Alderman MH. The effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease. Vasc Med. 2012 Dec;17(6):394-404. doi: 10.1177/1358863X12466709.
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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.
Seth I Sokol, MD principal investigator
Jacobi Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergocalciferol and Sugar pill in people with Vitamin D Deficiency and Coronary Artery Disease, run by Seth I. Sokol, M.D. at 2 sites 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 3 inclusion and 15 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 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Oct 2013). 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?
Endothelial Function (time frame: Baseline and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570309, which also lists 1 linked publication.
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 Oct 2013.