Trial Outcomes & Findings for Vitamin D Supplementation for Treatment of Heart Failure (NCT NCT01230307)

Last Updated: 2016-11-18

Results Overview

Biomarkers - C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), propeptide procollagen type I, plasma procollagen III, matrix metalloproteinase 2 (MMP-2), MMP-9 and tissue inhibitor of matrix metalloproteinases-1 (TIMP-1).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

6 months

Results posted on

2016-11-18

Participant Flow

16 consented participants were not randomized due to screen fails.

Participant milestones

Participant milestones
Measure	Vitamin D Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months	Placebo A placebo loading dose will be given followed by two placebo tablets daily for 6 months. Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Vitamin D Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months	Placebo A placebo loading dose will be given followed by two placebo tablets daily for 6 months. Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.
Overall Study LVAD Placement	0	2

Baseline Characteristics

Vitamin D Supplementation for Treatment of Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D n=6 Participants Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months	Placebo n=6 Participants A placebo loading dose will be given followed by two placebo tablets daily for 6 months. Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.	Total n=12 Participants Total of all reporting groups
Age, Customized 46 - 78 Years	6 participants n=93 Participants	6 participants n=4 Participants	12 participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Baseline Vit D level (ng/mL)	16.3 ng/mL STANDARD_DEVIATION 5 • n=93 Participants	19.6 ng/mL STANDARD_DEVIATION 3 • n=4 Participants	17.8 ng/mL STANDARD_DEVIATION 4 • n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Because enrollment was less than 30% of original goal (6 vs 4 subjects) and therefore would not have scientific validity and would be a waste of financial resources, this outcome was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Kansas City Cardiomyopathy Questionnaire for quality of life is measured on a scale of 0 - 100, with 100 being best.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity, in addition there is significant time and costs associated with this measurement which would result in data that would lead to no conclusions, this outcome was not analyzed.

Genotyped for the restricted fragment length polymorphism at the BsmI site. In addition CYP2R1, CYP27B1, CYP24 will also be genotyped.

Outcome measures

Outcome data not reported

Adverse Events

Vitamin D

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vitamin D n=6 participants at risk Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months	Placebo n=6 participants at risk A placebo loading dose will be given followed by two placebo tablets daily for 6 months. Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.
Gastrointestinal disorders GI bleed	16.7% 1/6 • Number of events 1 • 6 months	0.00% 0/6 • 6 months
Nervous system disorders syncope due to hypokalemia	16.7% 1/6 • Number of events 1 • 6 months	0.00% 0/6 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Barry Bleske

University of Michigan

Phone: 734-763-3232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place