NCT03649802

Vitamin D and Arterial Stiffness in Elderly

Treating Vitamin D Insufficiency in Community Dwelling Elderly to Improve Arterial Stiffness

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Texas Tech University Health Sciences Center · Academic / Other
• Sex: All
• Age: 65 Years – 89 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Vitamin D Deficiency
• Arterial Stiffness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low dose vitamin D3	Low dose arm-800 IU given daily
DIETARY_SUPPLEMENT	High dose vitamin D3	High dose arm-5000 IU given daily

Timeline

• Start date: 2018-08-16
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-08-28
• Last updated: 2022-03-21

Locations

1 site across 1 country: United States