Effects of Vitamin D on Cardiovascular Health in Black Women

NCT05656742 | Completed

• 1 other identifier: 1957713
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin d Deficiency

Keywords

vitamin D; black women; blood pressure; sleep; vascular

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (5)

• Change in brachial artery pulse wave analysis using the Sphygmocor XCEL system

  Change in pulse wave analysis measures from baseline, week 4, and week 8

• Change in carotid-femoral pulse wave velocity using the Sphygmocor XCEL system (m/s)

  Change in pulse wave velocity from baseline, week 4, and week 8

• Change in ultrasound-assessed common carotid pulsatility index

  Change in carotid pulsatility index from baseline, week 4, and week 8

• Change in ultrasound-assessed femoral artery blood flow response passive leg movement (PLM) (ml/min)

  Change in femoral blood flow response to PLM from baseline, week 4, and week 8

• Change in brachial artery flow-mediated dilation and reactive hyperemia

  Change in FMD responses from baseline, week 4, and week 8

Study Arms (1)

Vitamin D

EXPERIMENTAL

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

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

oral vitamin D3

Vitamin D

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Women assigned female at birth who currently identify as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Self-identified race is Black
• years old
• Serum 25-hydroxyvitamin D concentration between 8-29.9 ng/ml determined at screening visit

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Michele N D'Agata, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will receive the same intervention: 8 weeks of daily oral vitamin D3 supplements, each containing 5,000 IU

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 19, 2022
• Study Start: January 25, 2023
• Primary Completion: August 13, 2024
• Study Completion: January 1, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)