Effects of Vitamin D on Cardiovascular Health in Black Women

NCT ID: NCT05656742

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2025-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitamin D

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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

oral vitamin D3

Interventions

Vitamin D

oral vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Melissa Witman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele N D'Agata, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1957713

Identifier Type: -

Identifier Source: org_study_id