Vitamin D and Arterial Stiffness in Elderly

NCT03649802 | Completed Phase 2 DMC

• 1 other identifier: L18-174
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Arterial Stiffness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (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

  1 year

Study Arms (2)

Low dose Vitamin D-800 IU

PLACEBO COMPARATOR

Intervention includes low dose arm-800 IU given daily

Dietary Supplement: Low dose vitamin D3

High dose Vitamin D-5000 IU

ACTIVE COMPARATOR

Intervention includes high dose arm-5000 IU given daily

Dietary Supplement: High dose vitamin D3

Interventions

Low dose vitamin D3 DIETARY_SUPPLEMENT

Low dose arm-800 IU given daily

Low dose Vitamin D-800 IU

High dose vitamin D3 DIETARY_SUPPLEMENT

High dose arm-5000 IU given daily

High dose Vitamin D-5000 IU

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• (OH) Vitamin D value \< 30 ng/ml
• Subjects able to read and understand the English language

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Pooja N Sethi, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: August 16, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)