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NCT03070483 · ClinicalTrials.gov registry record · Phase 2
Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study
A Phase 2 study, sponsored by Loyola University.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03070483 is a Phase 2 study that has completed, run by Loyola University. The registered enrollment target is 5 participants.
The verdict
NCT03070483, a Phase 2 study, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Adequate levels of vitamin D are essential for bone health at all ages but low levels of vitamin D may also negatively impact other aspects of health such as blood pressure. The investigators have previously shown that adults with African ancestry living near the equator have much higher levels of vitamin D and higher levels of blood pressure compared to adults with African ancestry living in the Chicago area. Multiple clinical trials have examined vitamin D supplementation for reducing blood pressure levels but very few studies have focused on adults with African ancestry and low vitamin D levels. In addition, most previous clinical trials have not addressed calcium intake. While vitamin D may modulate blood pressure via its actions on activation of the renin angiotensin aldosterone system, it is also possible that vitamin D mediates blood pressure via its effects on gastrointestinal calcium absorption. This pilot study is a one arm study, which will assess the safety and feasibility of supplementing 15 young adults with African ancestry and low vitamin D levels with 5,000 IU of Cholecalciferol (vitamin D3) combined with 1000 mg of elemental calcium daily for 3 months. Participants will be recruited from the Maywood Illinois and surrounding areas with flyers and brochures. The investigators will also contact previous participants of the Modeling the Epidemiologic Study/Vitamin D Ancillary Study by phone and letters. At baseline, all participants will have blood pressure measured and will provide a fasting serum specimen and a 24-hour urine collection. Calcium, parathyroid hormone level vitamin D will be measured in serum specimens and 24-hour urine calcium excretion will be measured. Repeat visits will be completed at 6 and 12 weeks of follow-up to again measure resting blood pressure and serum calcium and vitamin D levels. The overall goal is to collect pilot data to help design a larger trial of vitamin D and calcium supplementation for lowering blood pressure in
Interventions
- DRUG Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-03-25 |
| Est. Completion | 2018-11-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03070483
The ClinicalTrials.gov registry entry for NCT03070483 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loyola University, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol is the first listed.
NCT03070483 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03070483 about?
NCT03070483 is a clinical study titled "Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study". Adequate levels of vitamin D are essential for bone health at all ages but low levels of vitamin D may also negatively impact other aspects of health such as blood pressure. The investigators have previously shown that adults with African ancestry living near the equator have much higher levels of v...
What is the current status of trial NCT03070483?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2018-03-25. Estimated completion is 2018-11-01.
What interventions are being tested in trial NCT03070483?
The interventions under investigation include: Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT03070483?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
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