Trial Outcomes & Findings for Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study (NCT NCT03070483)

Last Updated: 2020-06-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Difference in BP from baseline and 12 weeks after initiation of intervention

Results posted on

2020-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin D Arm All participants received cholecalciferol 5000 IU orally and calcium citrate 1000 mg orally daily for 12 weeks
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Vitamin D Arm All participants received cholecalciferol 5000 IU orally and calcium citrate 1000 mg orally daily for 12 weeks
Overall Study Lost to Follow-up	2

Baseline Characteristics

Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D n=5 Participants Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months Cholecalciferol: 5000 IU cholecalciferol with 1000 mg calcium citrate daily
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	38.4 years n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants
Mean arterial blood pressure	90 mmHg n=99 Participants

PRIMARY outcome

Timeframe: Difference in BP from baseline and 12 weeks after initiation of intervention

Outcome measures

Outcome measures
Measure	Vitamin D Arm n=3 Participants All participants received vitamin D and calcium supplementation
Change in Mean Blood Pressure From Baseline to 12 Weeks	4.3 mmHg Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D Arm n=3 Participants All participants received vitamin D and calcium supplementation
Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks	21.7 ng/ml Interval 9.0 to 39.0

SECONDARY outcome

Timeframe: Baseline and at 12 weeks after initiation of intervention

Population: We did not measure free vitamin D and only measured total vitamin D because we ran out of funding

Free 25(OH)D levels-will be measured using kits from Future Diagnostics (Wijchen, The Netherlands).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in PTH levels from baseline and at 12 weeks after initiation of intervention

Population: 3 participants who completed the trial

Intact parathyroid hormone levels will be measured with the use of the Elecsys Parathyroid Hormone Immunoassay

Outcome measures

Outcome measures
Measure	Vitamin D Arm n=3 Participants All participants received vitamin D and calcium supplementation
Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks	27.5 pg/ml Interval 13.0 to 52.5

SECONDARY outcome

Timeframe: Change in 1,25 dihydroxyvitamin D levels from baseline and at 12 weeks after initiation of intervention

Population: 1,25 vitamin D was never measured due to lack of funding

1,25 -dihydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention

Population: 3 participants who completed the trial

A 24-hour urine will be collected and calcium will be measured by Quest diagnostics

Outcome measures

Outcome measures
Measure	Vitamin D Arm n=3 Participants All participants received vitamin D and calcium supplementation
Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks	336.2 mg/day Interval -6.0 to 632.6

Adverse Events

Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Holly Kramer

Loyola University Chicago

Phone: 7083279039

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place