HypertensionAdDReaCHNCT01360476
Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients
A study testing cholecalciferol (Vitamin D) in people with Hypertension and Left Ventricular Hypertrophy, run by Wayne State University at 1 site in United States.
Trial summary
This project seeks to reduce the disparity in hypertensive heart disease which exists for African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure (BP). Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Hypertension, Left Ventricular Hypertrophy
- What is being tested?
- cholecalciferol (Vitamin D)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Nov 2015
- 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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with known HTN
- African-American race (self reported)
- Repeat SBP ≥ 160 mmHg within 1 hour of arrival
- Age 30-74 years
- Asymptomatic state (class I as defined by Goldman Specific Activity Scale)
Who cannot join
- Dyspnea (exertional, rest or nocturnal) or chest pain as a primary or secondary chief complaint
- Prior history of HF, coronary artery disease, myocardial infarction, cardiomyopathy (any), valvular heart disease (any) or renal failure with current, previous, or planned future dialysis
- Acute illness or injury which necessitates hospital admission
- Acute alcohol or cocaine intoxication or history of chronic alcohol (determined using the CAGE screening questions) or cocaine (self-reported) abuse
- Acute or decompensated psychiatric disorder or any underlying psychiatric disorder or cognitive deficit which precludes effective on-going communication or ability to follow-up as required
- Cancer (other than skin), HIV, or any other medical condition that might limit life expectancy
Show all 16Show fewer
- Hepatitis or liver enzyme (ALT, AST) elevations > 1.5x normal
- Planned move > 50 miles in the next 9 months
- History of kidney stones
- GFR <30
- Serum calcium > 10.5 mg/dl or known history of hypercalcemia
- History of or known primary hyperparathyroidism
- Sarcoidosis or other granulomatous disease
- Pregnant or planning to become pregnant
- Allergy or known hypersensitivity to gadolinium contrast
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ Cardiac Damage Among Vulnerable Hypertensive Patients
This project seeks to reduce the disparity in hypertensive heart disease which exists for African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject population which stands to benefit tremendously from better BP control and a corresponding decrease in heart damage. HTN occurs early in life and more often in African-Americans, reducing both quality and quantity of life. Inner-city African-Americans with HTN utilize the emergency department (ED) for chronic BP management. Like cardiovascular disease, vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to play an important role in cardiovascular health. Vitamin D replacement in those who are deficient has been thought to reduce the cardiovascular disease, especially if initiated early before irreversible damage has occurred, but this has yet to be tested in a prospective clinical trial. Accordingly, this proposal was designed to investigate the relationship between vitamin D and cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive patients without prior history of heart disease.
The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment, which, if shown to be effective could improve the existing approach to a widely accessible, cost-effective option.
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Being tested
- cholecalciferol (Vitamin D), Placebo
- Keywords
- hypertension, left ventricular hypertrophy, Vitamin D, African-Americans
- Medical subject headings
- Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol (Vitamin D)Dietary supplement
50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses)
PlaceboDietary supplement
chewable wafer every 2 weeks for 52 weeks (27 total doses)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Not described Receives: Dietary Supplement: cholecalciferol (Vitamin D) |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in left ventricular hypertrophy at 1 year
Cardiac MRI will be used to assess this change.
Measured: baseline, 16weeks, 52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Phillip D. Levy, Wayne State University
- Investigators
- Phillip D Levy, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360476
- Sponsor's protocol ID
- 1R01MD005849-01A1
- Acronym
- AdDReaCH
- Status last verified
- Dec 2015
- First submitted
- 19 May 2011
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ Cardiac Damage Among Vulnerable Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01360476
- Acronym / sponsor ID
- AdDReaCH / 1R01MD005849-01A1
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Keywords
- hypertension, left ventricular hypertrophy, Vitamin D, African-Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Aug 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 May 2011 (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.
This project seeks to reduce the disparity in hypertensive heart disease which exists for African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject population which stands to benefit tremendously from better BP control and a corresponding decrease in heart damage. HTN occurs early in life and more often in African-Americans, reducing both quality and quantity of life. Inner-city African-Americans with HTN utilize the emergency department (ED) for chronic BP management. Like cardiovascular disease, vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to play an important role in cardiovascular health. Vitamin D replacement in those who are deficient has been thought to reduce the cardiovascular disease, especially if initiated early before irreversible damage has occurred, but this has yet to be tested in a prospective clinical trial. Accordingly, this proposal was designed to investigate the relationship between vitamin D and cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive patients without prior history of heart disease.
The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment, which, if shown to be effective could improve the existing approach to a widely accessible, cost-effective option.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: cholecalciferol (Vitamin D) |
| placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with known HTN
- African-American race (self reported)
- Repeat SBP ≥ 160 mmHg within 1 hour of arrival
- Age 30-74 years
- Asymptomatic state (class I as defined by Goldman Specific Activity Scale)
Key exclusion criteria (16 listed)
- Dyspnea (exertional, rest or nocturnal) or chest pain as a primary or secondary chief complaint
- Prior history of HF, coronary artery disease, myocardial infarction, cardiomyopathy (any), valvular heart disease (any) or renal failure with current, previous, or planned future dialysis
- Acute illness or injury which necessitates hospital admission
- Acute alcohol or cocaine intoxication or history of chronic alcohol (determined using the CAGE screening questions) or cocaine (self-reported) abuse
- Acute or decompensated psychiatric disorder or any underlying psychiatric disorder or cognitive deficit which precludes effective on-going communication or ability to follow-up as required
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 |
|---|---|---|
| cholecalciferol (Vitamin D)50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses) | Dietary supplement | Vitamin D |
| Placebochewable wafer every 2 weeks for 52 weeks (27 total doses) | Dietary supplement | placebo |
Primary outcome
Change from Baseline in left ventricular hypertrophy at 1 year
Time frame: baseline, 16weeks, 52weeks
Cardiac MRI will be used to assess this change.
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 9 Dec 2015.
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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.
Phillip D Levy, MD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol (Vitamin D) in people with Hypertension and Left Ventricular Hypertrophy, run by Wayne State University 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 16 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 9 Dec 2015. 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?
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 left ventricular hypertrophy at 1 year (time frame: baseline, 16weeks, 52weeks). 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 9 Dec 2015.