Arterial Stiffness, Vitamin D Deficiency
Conditions
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTLow dose vitamin D3
Low dose arm-800 IU given daily
DIETARY_SUPPLEMENTHigh dose vitamin D3
High dose arm-5000 IU given daily
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The study coordinators will be aware of the allocation into the low and high dose vitamin D groups but the patient and the investigators will be blinded from this information.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
65 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis | 1 year | Indicator of arterial stiffness meters per second |
| 24 hour BP ambulatory monitoring | 1 year | Using Central and Brachial BP in mm Hg determination using Sphygmacor |
| Heart rate variability | 1 year | Using postural changes to assess heart rate variability in beats per minute using Sphygmacor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma sulphoraphane and F2-isoprostanes. Isoprostanes will be measured by gas chromatography mass spectrometry and sulphoraphane will be measured using LC-MS/MS techniques | 1 year | Markers for oxidative stress- both markers will be measured in ng/ml |
Countries
United States
Outcome results
None listed