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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | 5,000 IU of oral vitamin D3 in white powder form, daily for 8 continuous weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | oral vitamin D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women assigned female at birth who currently identify as female
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| Name | Affiliation | Role |
|---|---|---|
| Michele N D'Agata, PhD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38923277 | Derived | D'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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 30, 2023 | Jun 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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All participants will receive the same intervention: 8 weeks of daily oral vitamin D3 supplements, each containing 5,000 IU
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| 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 |
| 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 |
| 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 |
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |