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Vitamin D and Arterial Stiffness in Elderly

Primary Purpose

Vitamin D Deficiency, Arterial Stiffness

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low dose vitamin D3
High dose vitamin D3
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

65 Years - 89 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Low dose Vitamin D-800 IU

High dose Vitamin D-5000 IU

Arm Description

Intervention includes low dose arm-800 IU given daily

Intervention includes high dose arm-5000 IU given daily

Outcomes

Primary Outcome Measures

Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis
Indicator of arterial stiffness meters per second
24 hour BP ambulatory monitoring
Using Central and Brachial BP in mm Hg determination using Sphygmacor
Heart rate variability
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
Markers for oxidative stress- both markers will be measured in ng/ml

Full Information

First Posted
August 23, 2018
Last Updated
March 17, 2022
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT03649802
Brief Title
Vitamin D and Arterial Stiffness in Elderly
Official Title
Treating Vitamin D Insufficiency in Community Dwelling Elderly to Improve Arterial Stiffness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Arterial Stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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 year
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose Vitamin D-800 IU
Arm Type
Placebo Comparator
Arm Description
Intervention includes low dose arm-800 IU given daily
Arm Title
High dose Vitamin D-5000 IU
Arm Type
Active Comparator
Arm Description
Intervention includes high dose arm-5000 IU given daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Low dose vitamin D3
Intervention Description
Low dose arm-800 IU given daily
Intervention Type
Dietary Supplement
Intervention Name(s)
High dose vitamin D3
Intervention Description
High dose arm-5000 IU given daily
Primary Outcome Measure Information:
Title
Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis
Description
Indicator of arterial stiffness meters per second
Time Frame
1 year
Title
24 hour BP ambulatory monitoring
Description
Using Central and Brachial BP in mm Hg determination using Sphygmacor
Time Frame
1 year
Title
Heart rate variability
Description
Using postural changes to assess heart rate variability in beats per minute using Sphygmacor
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Plasma sulphoraphane and F2-isoprostanes. Isoprostanes will be measured by gas chromatography mass spectrometry and sulphoraphane will be measured using LC-MS/MS techniques
Description
Markers for oxidative stress- both markers will be measured in ng/ml
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja N Sethi, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States

12. IPD Sharing Statement

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Vitamin D and Arterial Stiffness in Elderly

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