Effects of Vitamin D on Cardiovascular Health in Black Women

Vitamin d Deficiency Clinical Trial

Official title:

Effects of Vitamin D on Cardiovascular Health in Black Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656742
• Other study ID #: 1957713
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: University of Delaware
• Contact: Michele N D'Agata, MS
• Phone: 860-461-8503
• Email: dagatami[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin d Deficiency

Intervention

Dietary Supplement:
• Vitamin D
oral vitamin D3

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from baseline blood pressure values at 4 weeks and 8 weeks.
Primary	Change in objectively estimated sleep duration and sleep efficiency 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 efficiency will be calculated as (total time asleep/total time in bed)*100%. Changes from baseline will be compared at week 4 and week 8.	Change from baseline sleep duration and sleep efficiency at 4 weeks and 8 weeks.
Primary	Change in serum 25(OH)D concentration	Serum 25-hydroxyvitamin D concentration will be clinically assessed via Labcorp testing services.	Change from baseline 25(OH)D at 4 weeks and 8 weeks.
Secondary	Change in brachial artery pulse wave analysis using the Sphygmocor XCEL system	Brachial systolic and diastolic blood pressure (BP) will be measured using the Sphygmocor XCEL system and central BP, augmentation index, and arterial wave reflections will be estimated via partial cuff inflation. Changes from baseline will be compared at week 4 and week 8.	Change in pulse wave analysis measures from baseline, week 4, and week 8
Secondary	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 pulse wave velocity from baseline, week 4, and week 8
Secondary	Change in ultrasound-assessed common carotid pulsatility index	An duplex PW-mode image of the common carotid artery will be recorded for 20 heart cycles using ultrasonography. Blood velocity will be evaluated directly on the ultrasound and pulsatility index will be calculated for each cardiac waveform as peak systolic velocity - end diastolic velocity / mean velocity and averaged over 20 cardiac cycles. Changes from baseline will be compared at week 4 and week 8.	Change in carotid pulsatility index from baseline, week 4, and week 8
Secondary	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.	Change in femoral blood flow response to PLM from baseline, week 4, and week 8
Secondary	Change in brachial artery flow-mediated dilation and reactive hyperemia	Brachial artery reactivity will be assessed via the flow-mediated dilation technique and percent dilation of the brachial artery in response to 5 minutes of forearm arterial occlusion will be assessed offline via Medical Imaging Applications Brachial Analyzer software. Brachial artery blood velocity will be measured on the ultrasound as mean velocity throughout the test and blood flow will be calculated using arterial diameter. Brachial artery blood flow area under the curve and peak brachial artery blood flow following cuff release will be assessed at baseline, week 4, and week 8.	Change in FMD responses from baseline, week 4, and week 8