Vitamin D and Arterial Stiffness in Elderly

Texas Tech University Health Sciences Center

Status and phase

Completed

Phase 2

Conditions

Vitamin D Deficiency

Arterial Stiffness

Treatments

Dietary Supplement: High dose vitamin D3

Dietary Supplement: Low dose vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT03649802

L18-174

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

65 to 89 years old

Volunteers

Accepts Healthy Volunteers

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