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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 from baseline 25(oh)d at 4 weeks and 8 weeks.
Awards & highlights
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~change from baseline 25(oh)d at 4 weeks and 8 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline 25(oh)d at 4 weeks and 8 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 efficiency using a Philips Actiwatch Spectrum Plus accelerometer wrist watch
Change in serum 25(OH)D concentration
Secondary study objectives
Change in brachial artery flow-mediated dilation and reactive hyperemia
Change in brachial artery pulse wave analysis using the Sphygmocor XCEL system
Change in carotid-femoral pulse wave velocity using the Sphygmocor XCEL system (m/s)
+2 more

Side effects data

From 2016 Phase 4 trial • 1366 Patients • NCT01709110
12%
Back pain
7%
Arthralgia
3%
Fall
1%
Humerus fracture
1%
Hip fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3670

Find a Location

Who is running the clinical trial?

University of DelawareLead Sponsor
162 Previous Clinical Trials
25,597 Total Patients Enrolled
Michele N D'Agata, MSPrincipal InvestigatorUniversity of Delaware

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05656742 — N/A
Vitamin D Deficiency Research Study Groups: Vitamin D
Vitamin D Deficiency Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05656742 — N/A
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05656742 — N/A
~9 spots leftby Dec 2025
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