Trial Outcomes & Findings for Evaluating Vitamin D3 Supplement on Post-Op Outcomes (NCT NCT04177758)

Results Overview

The functional component of the 2012 version of the knee society score at 3 weeks following surgery. Range 0-100. Assessed at 3 weeks following surgery, 3 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

137 participants

Primary outcome timeframe

Assessed at 3 weeks following surgery

Results posted on

2023-04-12

Participant Flow

Any patient undergoing primary total knee arthroplasty for osteoarthritis Age ≥ 18 years old Willingness to undergo randomization and return for all scheduled visits

Participant milestones

Participant milestones
Measure	Control Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Control: Patients randomized to the control will receive a placebo	Treatment Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
Overall Study STARTED	69	68
Overall Study COMPLETED	50	57
Overall Study NOT COMPLETED	19	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Control: Patients randomized to the control will receive a placebo	Treatment Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
Overall Study Lost to Follow-up	19	11

Baseline Characteristics

Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=50 Participants Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Control: Patients randomized to the control will receive a placebo	Treatment n=57 Participants Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.	Total n=107 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.	0 Participants n=57 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.	0 Participants n=107 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.
Age, Categorical Between 18 and 65 years	24 Participants n=50 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.	30 Participants n=57 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.	54 Participants n=107 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.
Age, Categorical >=65 years	26 Participants n=50 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.	27 Participants n=57 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.	53 Participants n=107 Participants • Total patients allocated to treatment- (n=68), however, n=11 were removed, therefore, n=57 received allocated intervention Total patients allocated to placebo (control) (n=69). However, n=19 were removed, therefore, n=50 received allocated intervention.
Age, Continuous	64.5 years STANDARD_DEVIATION 8.5 • n=50 Participants	63.7 years STANDARD_DEVIATION 9.5 • n=57 Participants	64.1 years STANDARD_DEVIATION 9 • n=107 Participants
Sex: Female, Male Female	27 Participants n=50 Participants	29 Participants n=57 Participants	56 Participants n=107 Participants
Sex: Female, Male Male	23 Participants n=50 Participants	28 Participants n=57 Participants	51 Participants n=107 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	50 Participants n=50 Participants	57 Participants n=57 Participants	107 Participants n=107 Participants

PRIMARY outcome

Timeframe: Assessed at 3 weeks following surgery

The functional component of the 2012 version of the knee society score at 3 weeks following surgery. Range 0-100. Assessed at 3 weeks following surgery, 3 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.

Outcome measures

Outcome measures
Measure	Control n=50 Participants Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Control: Patients randomized to the control will receive a placebo	Treatment n=57 Participants Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
Knee Society Score (KSS), Functional Component (2012) at 3 Weeks Post Operative	46.94 score on a scale Interval 14.0 to 90.0	50.89 score on a scale Interval 5.0 to 100.0

PRIMARY outcome

Timeframe: Assessed at 6 weeks following surgery reported

The functional component of the 2012 version of the knee society score at 6 weeks following surgery. Range 0-100. Assessed at 6 weeks following surgery, 6 weeks following surgery reported. For the 0-100 scale, Zero represents a worse outcome, deductions are taken away for using an assistive device and other physical exam factors. 100 would be the best score possible.

Outcome measures

Outcome measures
Measure	Control n=50 Participants Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Control: Patients randomized to the control will receive a placebo	Treatment n=57 Participants Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
Knee Society Score (KSS) at 6 Weeks Following Surgery	55.43 score on a scale Interval 10.39 to 91.0	60.38 score on a scale Interval 22.0 to 100.0

SECONDARY outcome

Timeframe: Assessed at 3 weeks following surgery

A timed up and go (TUG) test at 3 weeks following surgery. The TUG test consists of measuring the time it takes for an individual to rise from a seated position in a chair, walk to a mark 3 meters away, turn around, come back, and sit in the same chair from which they started. Patients will be asked to perform the test twice at each of the aforementioned encounters. The use of any assistive devices such as cane or a walker) will also be noted.

Outcome measures

Outcome measures
Measure	Control n=50 Participants Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Control: Patients randomized to the control will receive a placebo	Treatment n=57 Participants Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
Timed up and go Test at 3 Weeks Post Surgery	13.35 seconds Interval 7.42 to 31.94	13.46 seconds Interval 6.83 to 54.38

SECONDARY outcome

Timeframe: value at 6 weeks minus value at baseline

A timed up and go (TUG) test difference from baseline and at 6 weeks following surgery. The TUG test consists of measuring the time it takes for an individual to rise from a seated position in a chair, walk to a mark 3 meters away, turn around, come back, and sit in the same chair from which they started. Patients will be asked to perform the test twice at each of the aforementioned encounters. The use of any assistive devices such as cane or a walker) will also be noted.

Outcome measures

Outcome measures
Measure	Control n=50 Participants Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Control: Patients randomized to the control will receive a placebo	Treatment n=57 Participants Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
Timed up and go Test Difference From Baseline to 6 Weeks After Surgery	-0.9 seconds Interval -14.5 to 11.7	-0.3 seconds Interval -14.2 to 9.3

SECONDARY outcome

Timeframe: 6 weeks following surgery

Occurrence of any of the Knee Society's Standardized List of Complications

Outcome measures

Outcome measures
Measure	Control n=50 Participants Patients randomized to the control arm will receive placebo tablets and advised to consume their medication similar to the treatment arm. Control: Patients randomized to the control will receive a placebo	Treatment n=57 Participants Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery. Vitamin D: Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
Number of Participants With Complications	4 Participants	5 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment

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

Anne DeBenedetti, MSc

Rush University Medical Center

Phone: 312-432-2468

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place