Vitamin D Deficiency Clinical Trial
Official title:
Treating Vitamin D Insufficiency in Community Dwelling Elderly to Improve Arterial Stiffness
Verified date | March 2022 |
Source | Texas Tech University Health Sciences Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 89 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis | Indicator of arterial stiffness meters per second | 1 year | |
Primary | 24 hour BP ambulatory monitoring | Using Central and Brachial BP in mm Hg determination using Sphygmacor | 1 year | |
Primary | Heart rate variability | Using postural changes to assess heart rate variability in beats per minute using Sphygmacor | 1 year | |
Secondary | 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 | 1 year |
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