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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: Completed Phase 2 study, sponsored by Loyola University.

NCT03070483 is a Phase 2 study that has completed, run by Loyola University. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Seated blood pressure is measured at baseline and at 6 and 12 week follow-up visits in the clinic using an appropriate sized cuff after a rest period using an automated device (Omron). Blood pressure will be measured three times in one minute intervals at each time point and the average of these three recordings will be recorded as the mean blood pressure at each time point. Arm circumference will be measured to ensure the correct cuff size is used for all blood pressure measurements including h

Interventions

  • DRUG Cholecalciferol

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2018-03-25
Est. Completion 2018-11-01
Phase Phase 2
Loyola University

92 total trials

What the finished NCT03070483 record still lists

NCT03070483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol is the first listed.

NCT03070483 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03070483's enrollment target sits among peer trials

5 2000th of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03070483, the US trial registry maintained by the National Library of Medicine. NCT03070483 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.