Vitamin D and Arterial Stiffness in Elderly

Completed · Phase 2

Conditions studied: Vitamin D Deficiency, Arterial Stiffness

In brief

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.

Key facts

Study ID

NCT03649802

Run by

Texas Tech University Health Sciences Center

People needed

52

Starts

2018-08-16

Expected to finish

2021-12-31

Last updated by the study team

2022-03-21

Who can join

Age: 65 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Texas Tech University Health Sciences Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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