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Vitamin D and Arterial Stiffness in Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649802
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2018
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : August 16, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. Carotid-femoral pulse wave velocity measured by equipment provided by Complior pulse wave analysis [ Time Frame: 1 year ]
    Indicator of arterial stiffness meters per second

  2. 24 hour BP ambulatory monitoring [ Time Frame: 1 year ]
    Using Central and Brachial BP in mm Hg determination using Sphygmacor

  3. Heart rate variability [ Time Frame: 1 year ]
    Using postural changes to assess heart rate variability in beats per minute using Sphygmacor


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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649802


Locations
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United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Alan N Peiris, MD, PhD Texas Tech University Health Sciences Center

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT03649802    
Other Study ID Numbers: L18-174
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents