Vitamin D and Arterial Stiffness in Elderly

Sponsor

Texas Tech University Health Sciences Center (Other)

Overall Status

Completed

CT.gov ID

NCT03649802

Collaborator

(none)

Enrollment

Location

Arms

40.5

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Arterial Stiffness	Dietary Supplement: Low dose vitamin D3 Dietary Supplement: High dose vitamin D3	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will be randomized in a double blind manner. Arterial stiffness and oxidative stress markers will be evaluated in the low dose Vitamin D (800 IU) versus a high dose vitamin D (5000 IU) over a period of a yearSubjects will be randomized in a double blind manner. Arterial stiffness and oxidative stress markers will be evaluated in the low dose Vitamin D (800 IU) versus a high dose vitamin D (5000 IU) over a period of a year

Masking:

Double (Participant, Investigator)

Masking Description:

The study coordinators will be aware of the allocation into the low and high dose vitamin D groups but the patient and the investigators will be blinded from this information.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 16, 2018

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Plasma sulphoraphane and F2-isoprostanes. Isoprostanes will be measured by gas chromatography mass spectrometry and sulphoraphane will be measured using LC-MS/MS techniques [1 year]
Markers for oxidative stress- both markers will be measured in ng/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Tech University Health Sciences Center	Lubbock	Texas	United States	79430

Sponsors and Collaborators

Texas Tech University Health Sciences Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Texas Tech University Health Sciences Center

ClinicalTrials.gov Identifier:

NCT03649802

Other Study ID Numbers:

L18-174

First Posted:

Aug 28, 2018

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2022