Trial Outcomes & Findings for A Trial of Vitamin D Therapy in Patients With Heart Failure (NCT NCT01125436)

Results Overview

Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

change from baseline to 6 months

Results posted on

2022-08-10

Participant Flow

recruitment May 2007-April 2011 outpatient heart failure and cardiology clinics

Participant milestones

Participant milestones
Measure	Cholecalciferol + Calcium Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months	Placebo +Calcium Cholecalciferol : Placebo weekly for 6 months
Overall Study STARTED	31	33
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	12	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Vitamin D Therapy in Patients With Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cholecalciferol + Calcium n=31 Participants Participants received vitamin D	Placebo + Calcium n=33 Participants Participants received placebo	Total n=64 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 10.6 • n=5 Participants	66.0 years STANDARD_DEVIATION 10.4 • n=7 Participants	65.9 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	33 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: change from baseline to 6 months

Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity

Outcome measures

Outcome measures
Measure	Cholecalciferol + Calcium n=24 Participants Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months	Placebo +Calcium n=23 Participants Cholecalciferol : Placebo weekly for 6 months
Peak VO2	-.17 ml/kg/min Standard Deviation 2.07	-.68 ml/kg/min Standard Deviation 1.85

SECONDARY outcome

Timeframe: change from baseline to 6 months

Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension

Outcome measures

Outcome measures
Measure	Cholecalciferol + Calcium n=24 Participants Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months	Placebo +Calcium n=24 Participants Cholecalciferol : Placebo weekly for 6 months
Leg Proximal Muscle Strength Flexion 60°s-1	1.6 newton-meters/kg Standard Deviation 17.2	5.1 newton-meters/kg Standard Deviation 8.8
Leg Proximal Muscle Strength Extension 60°s-1	5.2 newton-meters/kg Standard Deviation 29.7	3.5 newton-meters/kg Standard Deviation 17.1

SECONDARY outcome

Timeframe: Change from baseline to 6 months

The six-minute walk test is a reliable and valid test of aerobic capacity, predictive of morbidity and mortality outcome, and correlates with Activity of Daily Living (ADL) and Quality of Living (QOL).

Outcome measures

Outcome measures
Measure	Cholecalciferol + Calcium n=24 Participants Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months	Placebo +Calcium n=26 Participants Cholecalciferol : Placebo weekly for 6 months
6 Minute Walk Distance	59 meters Standard Deviation 282	36 meters Standard Deviation 228

SECONDARY outcome

Timeframe: Change from baseline to 6 months

stand from chair walk 3 meters, return to chair and sit

Outcome measures

Outcome measures
Measure	Cholecalciferol + Calcium n=25 Participants Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months	Placebo +Calcium n=25 Participants Cholecalciferol : Placebo weekly for 6 months
Timed Get Up and Go	-0.2 seconds Standard Deviation 3.3	-1.0 seconds Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: change from baseline to 6 months

Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.

Outcome measures

Outcome measures
Measure	Cholecalciferol + Calcium n=31 Participants Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months	Placebo +Calcium n=31 Participants Cholecalciferol : Placebo weekly for 6 months
Serum Aldosterone	3.7 ng/dl Standard Deviation 13.65	-0.1 ng/dl Standard Deviation 15.55

OTHER_PRE_SPECIFIED outcome

Timeframe: change in renin from baseline to 6 months

Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol.

Outcome measures

Outcome measures
Measure	Cholecalciferol + Calcium n=29 Participants Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months	Placebo +Calcium n=28 Participants Cholecalciferol : Placebo weekly for 6 months
Plasma Renin Activity	1.3 ng/ml/hr Standard Deviation 13.84	-2.5 ng/ml/hr Standard Deviation 15.25

Adverse Events

Cholecalciferol + Calcium

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo +Calcium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cholecalciferol + Calcium n=31 participants at risk Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months	Placebo +Calcium n=33 participants at risk Cholecalciferol : Placebo weekly for 6 months
Cardiac disorders hospitalization	9.7% 3/31 • Number of events 3	0.00% 0/33

Other adverse events

Adverse event data not reported

Additional Information

Research Compliance Officer

Case Western Reserve University

Phone: 216-368-0134

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place