Trial Outcomes & Findings for High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status (NCT NCT01689779)

Results Overview

3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

Results posted on

2017-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Cholecalciferol 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol	Sugar Pill 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill
Overall Study STARTED	28	32
Overall Study COMPLETED	28	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cholecalciferol n=28 Participants 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol	Sugar Pill n=32 Participants 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill	Total n=60 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 13 • n=5 Participants	61 years STANDARD_DEVIATION 13 • n=7 Participants	57 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

Population: Data are presented as percent change in levels between baseline assessment and day of surgery

3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37

Outcome measures

Outcome measures
Measure	Cholecalciferol n=28 Participants 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol	Sugar Pill n=32 Participants 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill
Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol	8 percent change in 25(OH)D Standard Deviation 6	-2 percent change in 25(OH)D Standard Deviation 4

PRIMARY outcome

Timeframe: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

Population: Data are presented as percent change in levels between baseline assessment and day of surgery

3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37

Outcome measures

Outcome measures
Measure	Cholecalciferol n=28 Participants 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol	Sugar Pill n=32 Participants 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill
Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol	-10 percent change in LL-37 Standard Deviation 17	-5 percent change in LL-37 Standard Deviation 12

SECONDARY outcome

Timeframe: Patients will be followed between the day of surgery and 1 day after surgery

Population: Data are presented as percent change in levels between baseline assessment and day after surgery

The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=28 Participants 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol	Sugar Pill n=32 Participants 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill
Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery	-5 Percent change in 25(OH)D Standard Deviation 6	-4 Percent change in 25(OH)D Standard Deviation 4

SECONDARY outcome

Timeframe: Patients will be followed between the day of surgery and 1 day after surgery

Population: Data are presented as percent change in levels between baseline assessment and day after surgery

The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=28 Participants 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol	Sugar Pill n=32 Participants 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill
Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery	-3 Percent change in LL-37 Standard Deviation 24	-5 Percent change in LL-37 Standard Deviation 31

OTHER_PRE_SPECIFIED outcome

Timeframe: Patients will be followed between the day of surgery and an average duration of 14 days after surgery

Population: Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery

The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=28 Participants 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol	Sugar Pill n=32 Participants 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill
Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery	3 Percent change in 25(OH)D Standard Deviation 7	1 Percent change in 25(OH)D Standard Deviation 11

OTHER_PRE_SPECIFIED outcome

Timeframe: Patients will be followed between the day of surgery and an average duration of 14 days after surgery

Population: Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery

The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.

Outcome measures

Outcome measures
Measure	Cholecalciferol n=28 Participants 40 patients will receive 100,000 IU cholecalciferol orally 3-7 days before surgery. 100, 000 IU cholecalciferol	Sugar Pill n=32 Participants 40 patients will receive a sugar pill orally 3-7 days before surgery. Placebo: sugar pill
Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery	16 Percent change in LL-37 Standard Deviation 27	2 Percent change in LL-37 Standard Deviation 37

Adverse Events

Cholecalciferol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sadeq A. Quraishi, MD

Massachusetts General Hospital

Phone: 617-726-3030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place