A Phase 2 interventional study of Low dose vitamin D3 and High dose vitamin D3 in Vitamin D Deficiency and Arterial Stiffness, sponsored by Texas Tech University Health Sciences Center. Completed at 1 site in United States. Open to participants aged 65 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Texas Tech University Health Sciences Center · Phase 2, Interventional, and Treatment
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.
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.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 52 is below the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Texas Tech University Health Sciences Center is the lead sponsor of 97 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention includes low dose arm-800 IU given daily
Dietary Supplement: Low dose vitamin D3
Intervention includes high dose arm-5000 IU given daily
Dietary Supplement: High dose vitamin D3
Low dose arm-800 IU given daily
High dose arm-5000 IU given daily
Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis
Indicator of arterial stiffness meters per second
Time frame: 1 year
24 hour BP ambulatory monitoring
Using Central and Brachial BP in mm Hg determination using Sphygmacor
Time frame: 1 year
Heart rate variability
Using postural changes to assess heart rate variability in beats per minute using Sphygmacor
Time frame: 1 year
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
Time frame: 1 year
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center