Trial Outcomes & Findings for Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT00914810)

Results Overview

SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

39 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2013-06-11

Participant Flow

Participants from the Minneapolis Veterans Affairs Health Care System were recruited as a convenience sample between January 2009 and October 2011 from outpatient pulmonary clinics and an institutional review board-approved database of patients with COPD.

Participant milestones

Participant milestones
Measure	Placebo Placebo : Placebo (sugar pill) daily for 6 weeks	Vitamin D Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Overall Study STARTED	20	19
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo : Placebo (sugar pill) daily for 6 weeks	Vitamin D Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Overall Study Withdrawal by Subject	1	0
Overall Study Relocated out of state	1	0
Overall Study Hospitalized and unable to follow up.	0	1

Baseline Characteristics

Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=20 Participants Placebo : Placebo (sugar pill) daily for 6 weeks	Vitamin D n=19 Participants Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks	Total n=39 Participants Total of all reporting groups
Age Continuous Age	68 years STANDARD_DEVIATION 8 • n=5 Participants	67.6 years STANDARD_DEVIATION 7 • n=7 Participants	68 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo : Placebo (sugar pill) daily for 6 weeks	Vitamin D n=18 Participants Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Change in Short Physical Performance Battery (SPPB) Score	0.6 units on a scale Standard Deviation 1.7	0.9 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: 25-hydroxyvitamin D levels missing for 2 participants in the vitamin D arm of the trial.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo : Placebo (sugar pill) daily for 6 weeks	Vitamin D n=16 Participants Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)	-1.8 ng/mL Standard Deviation 3.1	8.7 ng/mL Standard Deviation 5.5

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D

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

Ken Kunisaki, M.D.

Minneapolis VA Health Care System

Phone: 612-467-4400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place