Trial Outcomes & Findings for Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity (NCT NCT01068418)

Last Updated: 2017-03-30

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

baseline and 1 month following vitamin D3 therapy

Results posted on

2017-03-30

Participant milestones
Measure	Vitamin D3 This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
Overall Study STARTED	26
Overall Study Medication Washout	17
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	12

Reasons for withdrawal
Measure	Vitamin D3 This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
Overall Study Physician Decision	12

Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity

Baseline characteristics by cohort
Measure	Vitamin D3 n=14 Participants This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
Age, Continuous	49.6 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 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	10 Participants n=5 Participants
Race (NIH/OMB) White	4 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	14 Participants n=5 Participants
Pre-Intervention Mean Arterial Pressure	105.6 mmHg STANDARD_DEVIATION 7.22 • n=5 Participants
Pre-Intervention 25-hydroxyvitamin D3	18.20 ng/mL STANDARD_DEVIATION 6.76 • n=5 Participants
Pre-Intervention Parathyroid hormone concentration	46.36 pg/mL STANDARD_DEVIATION 16.09 • n=5 Participants
Pre-Intervention Serum calcium concentration	8.94 mg/dL STANDARD_DEVIATION 0.30 • n=5 Participants

Timeframe: baseline and 1 month following vitamin D3 therapy

Outcome measures
Measure	Vitamin D3 n=14 Participants This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II	1.97 mmHg Standard Deviation 5.14

Timeframe: baseline and 1 month following vitamin D3 therapy

Outcome measures
Measure	Vitamin D3 n=14 Participants This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II	-20.0 mL/min/1.72m2 Standard Deviation 40.7

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Brigham and Women's Hospital, Harvard Medical School

Phone: 6177325666