Vitamin D and Arterial Stiffness in Elderly

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Arterial Stiffness
• Intervention / Treatment: Dietary supplement: Low dose vitamin D3; Dietary supplement: High dose vitamin D3

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 89 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Low dose Vitamin D-800 IU; Intervention includes low dose arm-800 IU given daily	Dietary supplement: Low dose vitamin D3; Low dose arm-800 IU given daily
ACTIVE_COMPARATOR: High dose Vitamin D-5000 IU; Intervention includes high dose arm-5000 IU given daily	Dietary supplement: High dose vitamin D3; High dose arm-5000 IU given daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis	Indicator of arterial stiffness meters per second	1 year
24 hour BP ambulatory monitoring	Using Central and Brachial BP in mm Hg determination using Sphygmacor	1 year
Heart rate variability	Using postural changes to assess heart rate variability in beats per minute using Sphygmacor	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Pooja N Sethi, MD, Texas Tech University Health Sciences Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 16, 2018
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (ACTUAL): August 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: L18-174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No