Vitamin D DeficiencyPhase 2NCT03649802
Vitamin D and Arterial Stiffness in Elderly
A Phase 2 study testing Low dose vitamin D3 and High dose vitamin D3 in people with Vitamin D Deficiency and Arterial Stiffness, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Investigators will examine arterial stiffness and pulse waveform analysis. Subjects with vitamin D insufficiency will be recruited. A double blind randomized controlled study will examine the effects of standard dose vitamin D3 (800 IU) versus higher dose vitamin D3 (5000 IU)-given on a daily basis.In order to… Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Arterial Stiffness
- What is being tested?
- Low dose vitamin D3 and High dose vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 31 Dec 2021
- 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 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community dwelling adults (Subjects) aged between 65 and 89 years of age
- Subjects should be ambulatory, living at home and capable of self-care
- Subjects should be able to drive an automobile independently and without assistance
- Subjects agree to home visitation by coordinators to assess pill counts or willing to come to TTUHSC for such a visit every 4 weeks ± 3 days
- 25(OH) Vitamin D value < 30 ng/ml
- Subjects able to read and understand the English language
Who cannot join
- Subjects unable or unwilling to have follow up for the duration of the study
- Subjects that cannot take a daily Vitamin D supplement or unwilling to have multiple blood draws
- Subjects on peritoneal or hemodialysis or a life expectancy less than 2 years
- Subjects with Sarcoidosis or diseases associated with hypercalcemia
- Subjects with prior cerebrovascular disease or memory problems
- Subjects with prior myocardial infarction or atrial fibrillation or on anticoagulants
- Subjects on medications for memory or cognitive issues or mental health
- Subjects unable to tolerate Sphygamocor and Complior testing protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Treating Vitamin D Insufficiency in Community Dwelling Elderly to Improve Arterial Stiffness
Investigators will examine arterial stiffness and pulse waveform analysis. Subjects with vitamin D insufficiency will be recruited. A double blind randomized controlled study will examine the effects of standard dose vitamin D3 (800 IU) versus higher dose vitamin D3 (5000 IU)-given on a daily basis.In order to understand mechanisms of action by which vitamin D would improve arterial stiffness investigators will use biomarkers. Oxidative and inflammatory stress will be measured by plasma F2-isoprostanes and Sulforaphane levels.
Read the detailed description
Cardiovascular disease disproportionately impacts the elderly. Current practice targets vascular disease with aggressive lipid lowering combined with brachial BP regulation, but has only achieved a modest degree of success. There is a need to intervene at a much earlier stage. Increased arterial stiffness is a marker for subclinical vascular disease and a sensitive predictor of ischemic stroke in the elderly. Vitamin D deficiency is linked to an increased risk of vascular disease.
There is an urgent need for well controlled randomized interventional studies in healthy elderly individuals demonstrating that vitamin D levels can improve vascular function in healthy elderly with vitamin D insufficiency. High dose vitamin D (5000 IU) replacement is required to improve systemic inflammation which may contribute to arterial stiffness and vascular aging.
The hypothesis is that daily 5000 IU vitamin D3 will regress or at least prevent progression of arterial stiffness as assessed by the carotid-femoral pulse wave velocity. Furthermore, investigators postulate that this improvement will be linked to improved oxidative and inflammatory status. Investigators will measure plasma measurements of Sulforaphane and plasma F2-isoprostane to assess the anti-oxidative mechanisms by which vitamin D could influence arterial stiffness.
- Conditions
- Vitamin D Deficiency, Arterial Stiffness
- Being tested
- Low dose vitamin D3, High dose vitamin D3
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose vitamin D3Dietary supplement
Low dose arm-800 IU given daily
High dose vitamin D3Dietary supplement
High dose arm-5000 IU given daily
| Study group | Role | What they receive |
|---|---|---|
| Low dose Vitamin D-800 IU | Placebo comparator | Intervention includes low dose arm-800 IU given daily Receives: Dietary Supplement: Low dose vitamin D3 |
| High dose Vitamin D-5000 IU | Active comparator | Intervention includes high dose arm-5000 IU given daily Receives: Dietary Supplement: High dose vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis
Indicator of arterial stiffness meters per second
Measured: 1 year
24 hour BP ambulatory monitoring
Using Central and Brachial BP in mm Hg determination using Sphygmacor
Measured: 1 year
Heart rate variability
Using postural changes to assess heart rate variability in beats per minute using Sphygmacor
Measured: 1 year
Secondary outcomes (1)
Plasma sulphoraphane and F2-isoprostanes. Isoprostanes will be measured by gas chromatography mass spectrometry and sulphoraphane will be measured using LC-MS/MS techniques
Markers for oxidative stress- both markers will be measured in ng/ml
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start16 Aug 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a double blind manner. Arterial stiffness and oxidative stress markers will be evaluated in the low dose Vitamin D (800 IU) versus a high dose vitamin D (5000 IU) over a period of a year
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pooja N Sethi, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649802
- Sponsor's protocol ID
- L18-174
- Status last verified
- Mar 2022
- First submitted
- 23 Aug 2018
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Vitamin D Insufficiency in Community Dwelling Elderly to Improve Arterial Stiffness
- ClinicalTrials.gov ID
- NCT03649802
- Acronym / sponsor ID
- L18-174
- Conditions
- Vitamin D Deficiency, Arterial Stiffness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Aug 2018 (actual)
- 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.
Investigators will examine arterial stiffness and pulse waveform analysis. Subjects with vitamin D insufficiency will be recruited. A double blind randomized controlled study will examine the effects of standard dose vitamin D3 (800 IU) versus higher dose vitamin D3 (5000 IU)-given on a daily basis.In order to understand mechanisms of action by which vitamin D would improve arterial stiffness investigators will use biomarkers. Oxidative and inflammatory stress will be measured by plasma F2-isoprostanes and Sulforaphane levels.
Detailed description
Cardiovascular disease disproportionately impacts the elderly. Current practice targets vascular disease with aggressive lipid lowering combined with brachial BP regulation, but has only achieved a modest degree of success. There is a need to intervene at a much earlier stage. Increased arterial stiffness is a marker for subclinical vascular disease and a sensitive predictor of ischemic stroke in the elderly. Vitamin D deficiency is linked to an increased risk of vascular disease.
There is an urgent need for well controlled randomized interventional studies in healthy elderly individuals demonstrating that vitamin D levels can improve vascular function in healthy elderly with vitamin D insufficiency. High dose vitamin D (5000 IU) replacement is required to improve systemic inflammation which may contribute to arterial stiffness and vascular aging.
The hypothesis is that daily 5000 IU vitamin D3 will regress or at least prevent progression of arterial stiffness as assessed by the carotid-femoral pulse wave velocity. Furthermore, investigators postulate that this improvement will be linked to improved oxidative and inflammatory status. Investigators will measure plasma measurements of Sulforaphane and plasma F2-isoprostane to assess the anti-oxidative mechanisms by which vitamin D could influence arterial stiffness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a double blind manner. Arterial stiffness and oxidative stress markers will be evaluated in the low dose Vitamin D (800 IU) versus a high dose vitamin D (5000 IU) over a period of a year
| Arm | Type | Receives |
|---|---|---|
| Low dose Vitamin D-800 IU | Placebo comparator | Dietary Supplement: Low dose vitamin D3Intervention includes low dose arm-800 IU given daily |
| High dose Vitamin D-5000 IU | Active comparator | Dietary Supplement: High dose vitamin D3Intervention includes high dose arm-5000 IU given daily |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Community dwelling adults (Subjects) aged between 65 and 89 years of age
- Subjects should be ambulatory, living at home and capable of self-care
- Subjects should be able to drive an automobile independently and without assistance
- Subjects agree to home visitation by coordinators to assess pill counts or willing to come to TTUHSC for such a visit every 4 weeks ± 3 days
- 25(OH) Vitamin D value < 30 ng/ml
Key exclusion criteria (8 listed)
- Subjects unable or unwilling to have follow up for the duration of the study
- Subjects that cannot take a daily Vitamin D supplement or unwilling to have multiple blood draws
- Subjects on peritoneal or hemodialysis or a life expectancy less than 2 years
- Subjects with Sarcoidosis or diseases associated with hypercalcemia
- Subjects with prior cerebrovascular disease or memory problems
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 |
|---|---|---|
| Low dose vitamin D3Low dose arm-800 IU given daily | Dietary supplement | Low dose Vitamin D-800 IU |
| High dose vitamin D3High dose arm-5000 IU given daily | Dietary supplement | High dose Vitamin D-5000 IU |
Primary outcome
Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis
Time frame: 1 year
Indicator of arterial stiffness meters per second
24 hour BP ambulatory monitoring
Time frame: 1 year
Using Central and Brachial BP in mm Hg determination using Sphygmacor
Heart rate variability
Time frame: 1 year
Using postural changes to assess heart rate variability in beats per minute using Sphygmacor
1 secondary outcome
Plasma sulphoraphane and F2-isoprostanes. Isoprostanes will be measured by gas chromatography mass spectrometry and sulphoraphane will be measured using LC-MS/MS techniques
Time frame: 1 year
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 21 Mar 2022.
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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.
Pooja N Sethi, MD principal investigator
Texas Tech University Health Sciences Center
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 Low dose vitamin D3 and High dose vitamin D3 in people with Vitamin D Deficiency and Arterial Stiffness, run by Texas Tech University Health Sciences Center 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 8 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 21 Mar 2022. 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.
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?
Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis (time frame: 1 year). The study lists 3 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 21 Mar 2022.