Vitamin d DeficiencyNCT05656742
Effects of Vitamin D on Cardiovascular Health in Black Women
A study testing Vitamin D in people with Vitamin d Deficiency, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin d Deficiency
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
- Being tested
- Vitamin D
- Keywords
- vitamin D, black women, blood pressure, sleep, vascular
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
oral vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | 5,000 IU of oral vitamin D3 in white powder form, daily for 8 continuous weeks Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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)
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.
Measured: Change in pulse wave velocity from baseline, week 4, and week 8
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Change in FMD responses from baseline, week 4, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start25 Jan 2023
- Primary completion13 Aug 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin d DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Witman, University of Delaware
- Investigators
- Michele N D'Agata, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656742
- Sponsor's protocol ID
- 1957713
- Status last verified
- Jan 2025
- First submitted
- 10 Nov 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Agata MN, Szymanski KM, Patterson F, Rattigan ML, Matias AA, Edwards DG, Martens CR, Ranadive SM, Witman MA. A pilot study investigating the effect of serum 25-hydroxyvitamin D on device-estimated sleep metrics in young black women: a single-arm open-label clinical trial. Sleep Adv. 2026 Sep 1;7(3):zpag096. doi: 10.1093/sleepadvances/zpag096. eCollection 2026.
PubMed 42769702D'agata MN, Hoopes EK, Keiser T, Patterson F, Szymanski KM, Matias AA, Brewer BC, Witman MA. Device-estimated sleep metrics do not mediate the relation between race and blood pressure dipping in young black and white women. J Clin Hypertens (Greenwich). 2024 Jul;26(7):850-860. doi: 10.1111/jch.14856. Epub 2024 Jun 26.
PubMed 38923277
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D on Cardiovascular Health in Black Women
- ClinicalTrials.gov ID
- NCT05656742
- Acronym / sponsor ID
- 1957713
- Conditions
- Vitamin d Deficiency
- Keywords
- vitamin D, black women, blood pressure, sleep, vascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same intervention: 8 weeks of daily oral vitamin D3 supplements, each containing 5,000 IU
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin D5,000 IU of oral vitamin D3 in white powder form, daily for 8 continuous weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin Doral vitamin D3 | Dietary supplement | Vitamin D |
Primary outcome
Change in 24-hour ambulatory systolic and diastolic blood pressure (mmHg) using an at-home ambulatory blood pressure monitor.
Time frame: Change from baseline blood pressure values at 4 weeks and 8 weeks.
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 efficiency using a Philips Actiwatch Spectrum Plus accelerometer wrist watch
Time frame: Change from baseline sleep duration and sleep efficiency at 4 weeks and 8 weeks.
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 in serum 25(OH)D concentration
Time frame: Change from baseline 25(OH)D at 4 weeks and 8 weeks.
Serum 25-hydroxyvitamin D concentration will be clinically assessed via Labcorp testing services.
5 secondary outcomes
Change in brachial artery pulse wave analysis using the Sphygmocor XCEL system
Time frame: 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)
Time frame: Change in pulse wave velocity from baseline, week 4, and week 8
Change in ultrasound-assessed common carotid pulsatility index
Time frame: 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)
Time frame: 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
Time frame: Change in FMD responses from baseline, week 4, and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 42769702D'Agata MN, Szymanski KM, Patterson F, Rattigan ML, Matias AA, Edwards DG, Martens CR, Ranadive SM, Witman MA. A pilot study investigating the effect of serum 25-hydroxyvitamin D on device-estimated sleep metrics in young black women: a single-arm open-label clinical trial. Sleep Adv. 2026 Sep 1;7(3):zpag096. doi: 10.1093/sleepadvances/zpag096. eCollection 2026.
- Derived from this study: PubMed 38923277D'agata MN, Hoopes EK, Keiser T, Patterson F, Szymanski KM, Matias AA, Brewer BC, Witman MA. Device-estimated sleep metrics do not mediate the relation between race and blood pressure dipping in young black and white women. J Clin Hypertens (Greenwich). 2024 Jul;26(7):850-860. doi: 10.1111/jch.14856. Epub 2024 Jun 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele N D'Agata, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin d Deficiency, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour ambulatory systolic and diastolic blood pressure (mmHg) using an at-home ambulatory blood pressure monitor. (time frame: Change from baseline blood pressure values at 4 weeks and 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656742, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.