Vitamin D for Vitamin D Deficiency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vitamin D DeficiencyVitamin D - DietarySupplement
Eligibility
18 - 40
Female
What conditions do you have?
Select

Study 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 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 vitamin D3 supplementation (5,000 IU per day) improve objectively estimated sleep duration and regularity in generally healthy, young adult black women who are vitamin D deficient or insufficient at baseline? Does 8 weeks of 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? 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, participants will be randomized to take either 5,000 IU of vitamin D3 or a placebo pill 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 compare the vitamin D3 and placebo groups 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.

Eligible Conditions
  • Vitamin D Deficiency

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Change in pulse wave velocity from baseline, week 4, and week 8

Week 8
Change in 24-hour ambulatory systolic and diastolic blood pressure (mmHg) using an ambulatory blood pressure monitor.
Week 8
Change in objectively estimated sleep duration and sleep regularity using a Philips Actiwatch Spectrum Plus accelerometer
Week 8
Change in ultrasound-assessed common carotid artery intima-media thickness (mm)
Week 8
Change in ultrasound-assessed femoral artery blood flow response passive leg movement (PLM) (ml/min)
Week 8
Change in carotid-femoral pulse wave velocity using the Sphygmocor XCEL system (m/s)

Trial Safety

Side Effects for

Risedronate
12%Back pain
7%Arthralgia
3%Fall
1%Hip fracture
1%Humerus fracture
1%Osteoarthritis
1%Femur fracture
1%Lumbar vertebral fracture
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01709110) in the Risedronate ARM group. Side effects include: Back pain with 12%, Arthralgia with 7%, Fall with 3%, Hip fracture with 1%, Humerus fracture with 1%.

Trial Design

2 Treatment Groups

Vitamin D
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

65 Total Participants · 2 Treatment Groups

Primary Treatment: Vitamin D · Has Placebo Group · N/A

Vitamin D
DietarySupplement
Experimental Group · 1 Intervention: Vitamin D · Intervention Types: DietarySupplement
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
2013
Completed Phase 4
~3470

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change in pulse wave velocity from baseline, week 4, and week 8

Who is running the clinical trial?

University of DelawareLead Sponsor
135 Previous Clinical Trials
36,706 Total Patients Enrolled
Michele N D'Agata, MSPrincipal InvestigatorUniversity of Delaware

Eligibility Criteria

Age 18 - 40 · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You self-identify as black.
You are between 18 and 40 years old.
Your serum 25-hydroxyvitamin D concentration is between 8 and 29.9 nanograms per milliliter.