Trial Outcomes & Findings for Effectiveness of Vitamin D Supplementation (NCT NCT02513823)

NCT ID: NCT02513823

Last Updated: 2019-10-04

Results Overview

Changes in systolic and diastolic blood pressure will be measured at baseline and following vitamin D supplementation for 10 weeks in African American healthy pre-menopausal women

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: Baseline and 10 weeks
• Results posted on: 2019-10-04

Participant Flow

Participant milestones

Measure	Intervention 2,000 IU of vitamin D given to African American women for 10 weeks 2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks
Overall Study STARTED	27
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Intervention 2,000 IU of vitamin D given to African American women for 10 weeks 2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks
Overall Study Lost to Follow-up	4
Overall Study Physician Decision	1

Baseline Characteristics

Effectiveness of Vitamin D Supplementation

Baseline characteristics by cohort

Measure	Intervention n=22 Participants 2,000 IU of vitamin D given to African American women for 10 weeks 2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 10 weeks

Changes in systolic and diastolic blood pressure will be measured at baseline and following vitamin D supplementation for 10 weeks in African American healthy pre-menopausal women

Outcome measures

Measure	Intervention n=22 Participants 2,000 IU of vitamin D given to African American women for 10 weeks 2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks
Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure SPB at Baseline	124 mmHg Standard Deviation 12
Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure SBP at 10 Weeks	125 mmHg Standard Deviation 10
Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure DBP at baseline	79 mmHg Standard Deviation 11
Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure DBP at 10 weeks	81 mmHg Standard Deviation 10

SECONDARY outcome

Timeframe: Baseline and 10 weeks

Changes of endothelial function at baseline and following 10 weeks of vitamin D supplementation as measured by pulse amplitude tonometry (PAT) fingertip plethysmography. Endothelial dysfunction was classified as a Reactive Hyperemic Index (RHI) of < 1.67 . RHI scale typical ranges from 1.0 to 3.0.

Outcome measures

Measure	Intervention n=22 Participants 2,000 IU of vitamin D given to African American women for 10 weeks 2,000 International Units (IU)of vitamin D3: 2,000 IU vitamin D taken daily for 10 weeks
Effectiveness of Vitamin d Supplementation on Improving Endothelial Function Reactive Hyperemia Index Baseline	2.1 units on a scale Standard Deviation 0.6
Effectiveness of Vitamin d Supplementation on Improving Endothelial Function Reactive Hyperemia Index 10 Weeks	2.0 units on a scale Standard Deviation 0.5

Adverse Events

Intervention

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

Carolyn Moore

Texas Woman's University

Phone: 713-794-2377

Email: cmoore8@twu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place