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Effects of Vitamin D on Cardiovascular Health in Black Women

Primary Purpose

Vitamin d Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin d Deficiency focused on measuring vitamin D, black women, blood pressure, sleep, vascular

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female Self-identified race is Black 18-30 years old Serum 25-hydroxyvitamin D concentration between 8-29.9 ng/ml determined at screening visit Exclusion Criteria: Unwilling or unable to give consent Unwilling or unable to undergo a venous blood draw Diagnosed with any chronic diseases or conditions including cardiometabolic diseases, cardiorespiratory diseases, chronic mental or psychological illness, musculoskeletal diseases/conditions, autoimmune diseases, cancer, gastrointestinal/malabsorption disorders, hyper-/hypocalcemia, hyper-/hypoparathyroidism, hyper-/hypothyroidism, kidney disease, or a history of kidney stones Taking medication that may influence blood pressure or blood vessel function Diagnosed with a sleep disorder (e.g., insomnia, restless leg syndrome, sleep apnea), or are at high risk for a sleep disorder according to the ISI (score >14) or STOP-bang (score ≥3) questionnaires Currently taking medications or supplements that affect sleep (e.g., Ambien, sedatives, melatonin, etc.) Currently working night-shift work Resting blood pressure >130 or >80 mmHg BMI >30 kg/m2 Currently pregnant, breast feeding, peri-menopausal, or post-menopausal Currently use tobacco (≥1 cigarette in the last month) Had COVID-19 in the past 60 days Received the COVID-19 vaccine or booster within in the past 14 days

Sites / Locations

  • University of DelawareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D

Arm Description

5,000 IU of oral vitamin D3 in white powder form, daily for 8 continuous weeks

Outcomes

Primary Outcome Measures

Change in 24-hour ambulatory systolic and diastolic blood pressure (mmHg) using an at-home ambulatory blood pressure monitor.
Participants will undergo a 24-hour period of ambulatory systolic and diastolic blood pressure (mmHg) recording to evaluate diurnal systolic and diastolic blood pressure and nocturnal systolic and diastolic blood pressure.
Change in objectively estimated sleep duration and sleep regularity using a Philips Actiwatch Spectrum Plus accelerometer wrist watch
Participants will undergo a two-week period of objectively estimated sleep recording using the Actiwatch. Sleep duration will be calculated as the average time spent asleep each night (hours) and sleep regularity will be calculated as the standard deviation of nightly sleep durations (hours). Changes from baseline will be compared at week 4 and week 8.

Secondary Outcome Measures

Change in carotid-femoral pulse wave velocity using the Sphygmocor XCEL system (m/s)
Carotid to femoral pulse wave velocity (m/s) will be calculated using the Sphygmocor XCEL system. Changes from baseline will be compared at week 4 and week 8.
Change in ultrasound-assessed common carotid artery intima-media thickness (mm)
An end-diastolic gated B-Mode image of the common carotid artery will be recorded for 15 heart cycles using simultaneous 3-lead electrocardiogram and ultrasonography recording. The image will be evaluated using Carotid Studio Quipu Software to measure carotid artery intima-media thickness (mm). Changes from baseline will be compared at week 4 and week 8.
Change in ultrasound-assessed femoral artery blood flow response passive leg movement (PLM) (ml/min)
Femoral artery blood velocity and diameter will be continuously recorded using Doppler ultrasound for 1 minute at rest and during 1 minute of passive movement of the lower leg at the knee joint at a frequency of 1 hertz. Femoral artery blood flow will be calculated at baseline and during movement. The change in femoral artery blood flow will be calculated as peak blood flow during movement minus baseline blood flow. The change in femoral blood flow from baseline to peak is our assessment of femoral artery blood flow response to passive leg movement for which changes from baseline will be compared at week 4 and week 8.

Full Information

First Posted
November 10, 2022
Last Updated
June 13, 2023
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT05656742
Brief Title
Effects of Vitamin D on Cardiovascular Health in Black Women
Official Title
Effects of Vitamin D on Cardiovascular Health in Black Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

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

5. Study Description

Brief Summary
The goal of this clinical trial is to understand the effects of oral vitamin D3 supplementation on various cardiovascular risk factors in generally healthy, young adult black women who are vitamin D deficient or insufficient at baseline. The main questions it aims to answer are: Does 8 weeks of vitamin D3 supplementation (5,000 IU per day) improve 24 hour blood pressure metrics in generally healthy, young adult black women who are vitamin D deficient or insufficient at baseline? Does 8 weeks of vitamin D3 supplementation (5,000 IU per day) improve objectively estimated sleep duration and regularity in generally healthy, young adult black women who are vitamin D deficient or insufficient at baseline? Does 8 weeks of vitamin D3 supplementation (5,000 IU per day) improve various measures of blood vessel structure and function in generally healthy, young adult black women who are vitamin D deficient or insufficient at baseline? All participants will undergo baseline testing, which includes 2 continuous weeks of objective sleep monitoring using a sleep watch, one 24-hour period of ambulatory blood pressure monitoring, and one blood vessel function testing visit. Following baseline testing, vitamin D insufficient and deficient participants will be prescribed take 5,000 IU of vitamin D3 daily for 8 continuous weeks. Participants will undergo 2-weeks of sleep monitoring again during weeks 3-4 of the supplementation period and during weeks 7-8 of the supplementation period. Additionally, 24-hour blood pressure monitoring will be performed during week 4 and week 8, and blood vessel function testing will take place at the end of week 4 and again at the end of week 8. Researchers will assess the effect of the vitamin D3 supplementation intervention by comparing all values between baseline, week 4, and week 8 to see if there is any effect of vitamin D3 supplementation on 24-hour blood pressure, sleep duration and regularity, and blood vessel structure and function following 4 and 8 weeks of supplementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin d Deficiency
Keywords
vitamin D, black women, blood pressure, sleep, vascular

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the same intervention: 8 weeks of daily oral vitamin D3 supplements, each containing 5,000 IU
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
5,000 IU of oral vitamin D3 in white powder form, daily for 8 continuous weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
oral vitamin D3
Primary Outcome Measure Information:
Title
Change in 24-hour ambulatory systolic and diastolic blood pressure (mmHg) using an at-home ambulatory blood pressure monitor.
Description
Participants will undergo a 24-hour period of ambulatory systolic and diastolic blood pressure (mmHg) recording to evaluate diurnal systolic and diastolic blood pressure and nocturnal systolic and diastolic blood pressure.
Time Frame
Change from baseline blood pressure values at 4 weeks and 8 weeks.
Title
Change in objectively estimated sleep duration and sleep regularity using a Philips Actiwatch Spectrum Plus accelerometer wrist watch
Description
Participants will undergo a two-week period of objectively estimated sleep recording using the Actiwatch. Sleep duration will be calculated as the average time spent asleep each night (hours) and sleep regularity will be calculated as the standard deviation of nightly sleep durations (hours). Changes from baseline will be compared at week 4 and week 8.
Time Frame
Change from baseline sleep duration and regularity at 4 weeks and 8 weeks.
Secondary Outcome Measure Information:
Title
Change in carotid-femoral pulse wave velocity using the Sphygmocor XCEL system (m/s)
Description
Carotid to femoral pulse wave velocity (m/s) will be calculated using the Sphygmocor XCEL system. Changes from baseline will be compared at week 4 and week 8.
Time Frame
Change in pulse wave velocity from baseline, week 4, and week 8
Title
Change in ultrasound-assessed common carotid artery intima-media thickness (mm)
Description
An end-diastolic gated B-Mode image of the common carotid artery will be recorded for 15 heart cycles using simultaneous 3-lead electrocardiogram and ultrasonography recording. The image will be evaluated using Carotid Studio Quipu Software to measure carotid artery intima-media thickness (mm). Changes from baseline will be compared at week 4 and week 8.
Time Frame
Change in carotid intima-media thickness from baseline, week 4, and week 8
Title
Change in ultrasound-assessed femoral artery blood flow response passive leg movement (PLM) (ml/min)
Description
Femoral artery blood velocity and diameter will be continuously recorded using Doppler ultrasound for 1 minute at rest and during 1 minute of passive movement of the lower leg at the knee joint at a frequency of 1 hertz. Femoral artery blood flow will be calculated at baseline and during movement. The change in femoral artery blood flow will be calculated as peak blood flow during movement minus baseline blood flow. The change in femoral blood flow from baseline to peak is our assessment of femoral artery blood flow response to passive leg movement for which changes from baseline will be compared at week 4 and week 8.
Time Frame
Change in femoral blood flow response to PLM from baseline, week 4, and week 8

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women assigned female at birth who currently identify as female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Self-identified race is Black 18-30 years old Serum 25-hydroxyvitamin D concentration between 8-29.9 ng/ml determined at screening visit Exclusion Criteria: Unwilling or unable to give consent Unwilling or unable to undergo a venous blood draw Diagnosed with any chronic diseases or conditions including cardiometabolic diseases, cardiorespiratory diseases, chronic mental or psychological illness, musculoskeletal diseases/conditions, autoimmune diseases, cancer, gastrointestinal/malabsorption disorders, hyper-/hypocalcemia, hyper-/hypoparathyroidism, hyper-/hypothyroidism, kidney disease, or a history of kidney stones Taking medication that may influence blood pressure or blood vessel function Diagnosed with a sleep disorder (e.g., insomnia, restless leg syndrome, sleep apnea), or are at high risk for a sleep disorder according to the ISI (score >14) or STOP-bang (score ≥3) questionnaires Currently taking medications or supplements that affect sleep (e.g., Ambien, sedatives, melatonin, etc.) Currently working night-shift work Resting blood pressure >130 or >80 mmHg BMI >30 kg/m2 Currently pregnant, breast feeding, peri-menopausal, or post-menopausal Currently use tobacco (≥1 cigarette in the last month) Had COVID-19 in the past 60 days Received the COVID-19 vaccine or booster within in the past 14 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele N D'Agata, MS
Phone
860-461-8503
Email
dagatami@udel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa A Witman, PhD
Phone
302-831-6256
Email
mwitman@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele N D'Agata, MS
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele N D'Agata, MS
Phone
860-461-8503
Email
dagatami@udel.edu
First Name & Middle Initial & Last Name & Degree
Melissa A Witman, PhD
Phone
302-831-6256
Email
mwitman@udel.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Vitamin D on Cardiovascular Health in Black Women

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