Clinical trial NCT05656742: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin d Deficiency
Keywords: vitamin D
black women
blood pressure
sleep
vascular
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the same intervention: 8 weeks of daily oral vitamin D3 supplements, each containing 5,000 IU
Primary purpose: PREVENTION

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 oral 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 oral vitamin D3 supplementation (5,000 IU per day) improve subjective and objectively estimated sleep health metrics in generally healthy, young adult black women who are vitamin D deficient or insufficient at baseline?
* Does 8 weeks of oral 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?
* Does 8 weeks of oral vitamin D3 supplementation (5,000 IU per day) improve various measures of laboratory blood pressure regulation and autonomic function?

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.


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

Primary outcomes:
measure: Change in 24-hour ambulatory systolic and diastolic blood pressure (mmHg) using an at-home ambulatory blood pressure monitor.
timeFrame: Change from baseline blood pressure values at 4 weeks and 8 weeks.
measure: Change in objectively estimated sleep duration and sleep efficiency using a Philips Actiwatch Spectrum Plus accelerometer wrist watch
timeFrame: Change from baseline sleep duration and sleep efficiency at 4 weeks and 8 weeks.
measure: Change in serum 25(OH)D concentration
timeFrame: Change from baseline 25(OH)D at 4 weeks and 8 weeks.
Secondary outcomes:
measure: Change in brachial artery pulse wave analysis using the Sphygmocor XCEL system
timeFrame: Change in pulse wave analysis measures from baseline, week 4, and week 8
measure: Change in carotid-femoral pulse wave velocity using the Sphygmocor XCEL system (m/s)
timeFrame: Change in pulse wave velocity from baseline, week 4, and week 8
measure: Change in ultrasound-assessed common carotid pulsatility index
timeFrame: Change in carotid pulsatility index from baseline, week 4, and week 8
measure: Change in ultrasound-assessed femoral artery blood flow response passive leg movement (PLM) (ml/min)
timeFrame: Change in femoral blood flow response to PLM from baseline, week 4, and week 8
measure: Change in brachial artery flow-mediated dilation and reactive hyperemia
timeFrame: Change in FMD responses from baseline, week 4, and week 8
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Michele N D'Agata, PhD
role: PRINCIPAL_INVESTIGATOR
References: