Trial · NCT03070483
Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study
NCT03070483, Phase 2, Completed, Loyola University; results first posted 2020-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study. Trials, record NCT03070483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03070483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study
- NCT number
- NCT03070483
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Loyola University
- Conditions
- Hypertension, Vitamin D Deficiency
- Interventions
- Cholecalciferol
- First posted
- 2017-03-03
- Last updated
- 2020-06-24
- Results first posted
- 2020-06-24
- Limitations and caveats
- We only enrolled 5 participants and 3 completed the trial. The early termination led to small number of subjects analyzed. We did not measure free vitamin D or 1,25 vitamin D levels.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Blood Pressure From Baseline to 12 Weeks | Difference in BP from baseline and 12 weeks after initiation of intervention | 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 home monitoring of blood pressure. Due to small number of participants, the change in mean blood pressure was analyzed as difference in mean blood pressure (2 x average diastolic blood pressure + average systolic blood pressure)/3 between baseline and at 12 weeks. |
| Secondary | Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks | Change in total 25-hydroxyvitamin D level from baseline to 12 weeks after initiation of intervention | Total 25-hydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry |
| Secondary | Change in Free 25-hydroxyvitamin D Levels From Baseline to 12 Weeks | Baseline and at 12 weeks after initiation of intervention | Free 25(OH)D levels-will be measured using kits from Future Diagnostics (Wijchen, The Netherlands). |
| Secondary | Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks | Change in PTH levels from baseline and at 12 weeks after initiation of intervention | Intact parathyroid hormone levels will be measured with the use of the Elecsys Parathyroid Hormone Immunoassay |
| Secondary | Change in 1,25-dihydroxyvitamin D From Baseline to 12 Weeks | Change in 1,25 dihydroxyvitamin D levels from baseline and at 12 weeks after initiation of intervention | 1,25 -dihydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry |
| Secondary | Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks | Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention | A 24-hour urine will be collected and calcium will be measured by Quest diagnostics |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Blood Pressure From Baseline to 12 Weeks | Difference in BP from baseline and 12 weeks after initiation of intervention | mmHg | MEAN | |
| SECONDARY | Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks | Change in total 25-hydroxyvitamin D level from baseline to 12 weeks after initiation of intervention | ng/ml | MEAN | |
| SECONDARY | Change in Free 25-hydroxyvitamin D Levels From Baseline to 12 Weeks | Baseline and at 12 weeks after initiation of intervention | We did not measure free vitamin D and only measured total vitamin D because we ran out of funding | ||
| SECONDARY | Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks | Change in PTH levels from baseline and at 12 weeks after initiation of intervention | 3 participants who completed the trial | pg/ml | MEDIAN |
| SECONDARY | Change in 1,25-dihydroxyvitamin D From Baseline to 12 Weeks | Change in 1,25 dihydroxyvitamin D levels from baseline and at 12 weeks after initiation of intervention | 1,25 vitamin D was never measured due to lack of funding | ||
| SECONDARY | Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks | Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention | 3 participants who completed the trial | mg/day | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Blood Pressure From Baseline to 12 Weeks | Vitamin D Arm | 4.3 | Full Range 2 to 10 | mmHg | |
| Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks | Vitamin D Arm | 21.7 | Full Range 9 to 39 | ng/ml | |
| Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks | Vitamin D | 27.5 | Inter-Quartile Range 13.0 to 52.5 | pg/ml | |
| Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks | Vitamin D | 336.2 | Inter-Quartile Range -6.0 to 632.6 | mg/day |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vitamin D Arm | 5 | |
| Overall Study | COMPLETED | Vitamin D Arm | 3 | |
| Overall Study | NOT COMPLETED | Vitamin D Arm | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vitamin D | 0 | 5 |
| Total, other adverse events | Vitamin D | 0 | 5 |
| Total, serious adverse events | Vitamin D | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28118279 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03070483
GET https://conductscience.org/api/trials/v1/NCT03070483/registered