Vitamin D and Arterial Stiffness in Elderly
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Other Indications, Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 65 - 89 |
| Updated: | 1/31/2019 |
| Start Date: | June 1, 2019 |
| End Date: | December 31, 2021 |
| Contact: | Alan N Peiris, MD, PhD, FRCP |
| Email: | alan.peiris@ttuhsc.edu |
| Phone: | 806-743-1250 |
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.
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.
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.
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.
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 currently taking supplements containing vitamin D
- 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 on medications for Diabetes, hypertension, lipids or mental ill-health or
unable to tolerate Complior testing equipment
We found this trial at
1
site
Lubbock, Texas 79430
Principal Investigator: Alan N Peiris, MD, PhD
Phone: 806-743-4433
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