Trial Outcomes & Findings for Study of Vitamin D and Effect on Heart Disease and Insulin Resistance (NCT NCT01093417)

NCT ID: NCT01093417

Last Updated: 2016-07-14

Results Overview

Endothelial function measured by flow mediated brachial artery dilation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2016-07-14

Participant Flow

Participant milestones

Measure	Placebo 15 participants were randomized to matching placebo for 12 weeks	Vitamin D 4000 IU 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
Overall Study STARTED	15	30
Overall Study COMPLETED	15	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Vitamin D and Effect on Heart Disease and Insulin Resistance

Baseline characteristics by cohort

Measure	Placebo n=15 Participants 15 participants were randomized to matching placebo for 12 weeks	Vitamin D 4000 IU n=30 Participants 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	30 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40 years STANDARD_DEVIATION 10 • n=5 Participants	47 years STANDARD_DEVIATION 8 • n=7 Participants	45 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	25 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	30 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Endothelial function measured by flow mediated brachial artery dilation

Outcome measures

Measure	Placebo n=15 Participants 15 participants were randomized to matching placebo for 12 weeks	Vitamin D 4000 IU n=29 Participants 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
Change in Endothelial Function	0.29 percent change in endothelial function Interval -1.61 to 1.77	0.55 percent change in endothelial function Interval -1.05 to 2.13

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Measure	Placebo n=15 Participants 15 participants were randomized to matching placebo for 12 weeks	Vitamin D 4000 IU n=29 Participants 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
Change in Serum 25-hydroxyvitamin D Concentration in Both Groups	-1.8 ng/mL Interval -2.9 to 0.1	5.0 ng/mL Interval -0.9 to 7.4

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D 4000 IU

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

Grace McComsey, MD

University Hospitals Case Medical Center

Phone: 2168443607

Email: gam9@case.edu

Results disclosure agreements

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