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Vitamin D for Cardiovascular Health in Black Women with Vitamin D Deficiency
N/A
Recruiting
Led By Michele N D'Agata, MS
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in pulse wave velocity from baseline, week 4, and week 8
Awards & highlights
Study Summary
This trial will look at how vitamin D3 affects blood pressure, sleep, and blood vessel function in young black women who are vitamin D deficient or insufficient.
Who is the study for?
This trial is for young adult black women aged 18-30 who have low vitamin D levels but are generally healthy. They shouldn't have chronic diseases, sleep disorders, obesity (BMI >30), high blood pressure, or be using tobacco. They also can't be pregnant, menopausal, recently affected by COVID-19 or taking certain medications.Check my eligibility
What is being tested?
Researchers are testing if taking a daily dose of 5,000 IU vitamin D3 for 8 weeks affects cardiovascular health in these women. They'll check changes in blood pressure, sleep patterns and blood vessel function at the start of the study and after 4 and 8 weeks of supplementation.See study design
What are the potential side effects?
Vitamin D3 is usually safe but can sometimes cause side effects like nausea, fatigue, headache or increased calcium levels which might lead to kidney stones or other issues if taken excessively.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in pulse wave velocity from baseline, week 4, and week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in pulse wave velocity from baseline, week 4, and week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 24-hour ambulatory systolic and diastolic blood pressure (mmHg) using an at-home ambulatory blood pressure monitor.
Change in objectively estimated sleep duration and sleep regularity using a Philips Actiwatch Spectrum Plus accelerometer wrist watch
Secondary outcome measures
Change in carotid-femoral pulse wave velocity using the Sphygmocor XCEL system (m/s)
Change in ultrasound-assessed common carotid artery intima-media thickness (mm)
Change in ultrasound-assessed femoral artery blood flow response passive leg movement (PLM) (ml/min)
Side effects data
From 2016 Phase 4 trial • 1366 Patients • NCT0170911012%
Back pain
7%
Arthralgia
3%
Fall
1%
Hip fracture
1%
Humerus fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide
Trial Design
1Treatment groups
Experimental Treatment
Group I: Vitamin DExperimental Treatment1 Intervention
5,000 IU of oral vitamin D3 in white powder form, daily for 8 continuous weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
2013
Completed Phase 4
~3470
Find a Location
Who is running the clinical trial?
University of DelawareLead Sponsor
154 Previous Clinical Trials
25,186 Total Patients Enrolled
Michele N D'Agata, MSPrincipal InvestigatorUniversity of Delaware
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had COVID-19 within the last 60 days.I have been diagnosed with a sleep disorder or am at high risk based on ISI or STOP-bang scores.I am currently taking sleep medications or supplements.I am female.I have received a COVID-19 vaccine or booster in the last 14 days.I am on medication that can affect my blood pressure or how my blood vessels work.I am currently pregnant, breastfeeding, or going through menopause.I am between 18 and 30 years old.I have been diagnosed with a chronic disease or condition.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there enrollment opportunities currently available for this research?
"Presently, this clinical trial is recruiting participants as indicated by the records on clinicaltrials.gov. It was posted in December 1st 2022 and its most recent update was 12th of December 2022."
Answered by AI
Does this research opportunity extend to individuals aged 70 and above?
"This medical trial is exclusively for individuals between 18 and 40 years old. However, there are 13 other studies open to minors and 28 trials targeting elderly patients over 65."
Answered by AI
How many participants can be accepted into this research initiative?
"Correct. Evidence housed on clinicaltrials.gov affirms that this therapeutic trial, which was initially posted on December 1st 2022, is actively recruiting patients. Approximately 65 participants must be sourced from a solitary medical centre."
Answered by AI
Do I satisfy the requirements to partake in this clinical investigation?
"This clinical trial seeks out 65 individuals aged 18-40, who self-identify as black and have vitamin d deficiency with a serum 25-hydroxyvitamin D concentration between 8 - 29.9 ng/ml. Gender is limited to female applicants."
Answered by AI
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