Trial Outcomes & Findings for Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery? (NCT NCT04323852)

NCT ID: NCT04323852

Last Updated: 2021-10-19

Results Overview

Caspase 2 enzyme activity in right atrial specimen measured by with immunohistochemistry staining The positive control and negative control were taken from human lymph node tissue. as for the control tissue a humane lymph node was used. Positivity for active caspase is shown using cytoplasmic staining . the number of apoptotic cells was measure per each high power filed (HPF) under light microscopy.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: during the surgery, an average of 3 hours
• Results posted on: 2021-10-19

Participant Flow

Participant milestones

Measure	Vitamin D 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo	Total n=70 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 6 • n=35 Participants	58 years STANDARD_DEVIATION 9 • n=35 Participants	58.5 years STANDARD_DEVIATION 7 • n=70 Participants
Sex: Female, Male Female	8 Participants n=35 Participants	7 Participants n=35 Participants	15 Participants n=70 Participants
Sex: Female, Male Male	27 Participants n=35 Participants	28 Participants n=35 Participants	55 Participants n=70 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Iran	35 participants n=35 Participants	35 participants n=35 Participants	70 participants n=70 Participants
Ejection Fraction	47 percentage STANDARD_DEVIATION 10 • n=35 Participants	48 percentage STANDARD_DEVIATION 9 • n=35 Participants	47.5 percentage STANDARD_DEVIATION 8 • n=70 Participants
Myocardial infarction	19 Participants n=35 Participants	15 Participants n=35 Participants	34 Participants n=70 Participants
Erythrocyte sedimentation rate (ESR)	13 mm/hour STANDARD_DEVIATION 9 • n=35 Participants	14 mm/hour STANDARD_DEVIATION 8 • n=35 Participants	13.6 mm/hour STANDARD_DEVIATION 4 • n=70 Participants
BMI	27 kg/m^2 STANDARD_DEVIATION 3 • n=35 Participants	27 kg/m^2 STANDARD_DEVIATION 3 • n=35 Participants	27 kg/m^2 STANDARD_DEVIATION 1 • n=70 Participants
25 (OH)D	12.8 ng/mL STANDARD_DEVIATION 6 • n=35 Participants	12.1 ng/mL STANDARD_DEVIATION 5 • n=35 Participants	12.4 ng/mL STANDARD_DEVIATION 4 • n=70 Participants
Hyperlipidemia	9 Participants n=35 Participants	16 Participants n=35 Participants	25 Participants n=70 Participants
Diabetes Mellitus	12 Participants n=35 Participants	19 Participants n=35 Participants	31 Participants n=70 Participants
Hypertension	18 Participants n=35 Participants	22 Participants n=35 Participants	40 Participants n=70 Participants
Smokers	15 Participants n=35 Participants	21 Participants n=35 Participants	36 Participants n=70 Participants
Family history of cardiovascular disease	9 Participants n=35 Participants	8 Participants n=35 Participants	17 Participants n=70 Participants

PRIMARY outcome

Timeframe: during the surgery, an average of 3 hours

Caspase 2 enzyme activity in right atrial specimen measured by with immunohistochemistry staining The positive control and negative control were taken from human lymph node tissue. as for the control tissue a humane lymph node was used. Positivity for active caspase is shown using cytoplasmic staining . the number of apoptotic cells was measure per each high power filed (HPF) under light microscopy.

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Caspase 2 Enzyme Level	1.3 cells/ HPF Standard Deviation 1.0	2.0 cells/ HPF Standard Deviation 0.9

PRIMARY outcome

Timeframe: during the surgery, an average of 3 hours

Caspase 3 enzyme activity in right atrial specimen measured by with immunohistochemistry staining The positive control and negative control were taken from human lymph node tissue. as for the control tissue a humane lymph node was used. Positivity for active caspase is shown using cytoplasmic staining . the number of apoptotic cells was measure per each high power filed (HPF) under light microscopy.

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Caspase 3 Enzyme Level, an Average of 3 Hours	1.2 cells/ HPF Standard Deviation 0.8	2.0 cells/ HPF Standard Deviation 0.8

PRIMARY outcome

Timeframe: during the surgery, an average of 3 hours

Caspase 7 enzyme activity in right atrial specimen measured by with immunohistochemistry staining The positive control and negative control were taken from human lymph node tissue. as for the control tissue a humane lymph node was used. Positivity for active caspase is shown using cytoplasmic staining . the number of apoptotic cells was measure per each high power filed (HPF) under light microscopy.

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Caspase 7 Enzyme Level	1.3 cells/ HPF Standard Deviation 1.0	1.8 cells/ HPF Standard Deviation 1.2

PRIMARY outcome

Timeframe: Right before the intervention(3 days before surgery)

The concentration of IL-10 in the serum of patients was measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit .

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Interlukin-10 (IL-10) Serum Level	1.0 pg/ml Standard Deviation 0.35	1.0 pg/ml Standard Deviation 0

PRIMARY outcome

Timeframe: procedure (before anesthesia induction)

The concentration of IL-10 in the serum of patients was measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit .

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Interleukin-10 (IL-10) Serum Level	4.4 pg/ml Standard Deviation 4.9	1.0 pg/ml Standard Deviation 0

PRIMARY outcome

Timeframe: at the end of surgery after protamine reversal

The concentration of IL-10 in the serum of patients was measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit .

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Interleukin--10 (IL-10) Serum Level	304.8 pg/ml Standard Deviation 85.6	205.5 pg/ml Standard Deviation 107.4

PRIMARY outcome

Timeframe: the first postoperative day

The concentration of IL-10 in the serum of patients was measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit .

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Interleukin (IL-10) Serum Level	7.6 pg/ml Standard Deviation 6.5	4.0 pg/ml Standard Deviation 6.7

PRIMARY outcome

Timeframe: Right before the intervention(3 days before surgery)

The concentration of the IGF-1 was also measured by a quantitative ELISA kit

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Insulin Growth Factor	86.3 ng/mL Standard Deviation 33.9	76.5 ng/mL Standard Deviation 26.6

PRIMARY outcome

Timeframe: procedure (before anesthesia induction)

The concentration of the IGF-1 was also measured by a quantitative ELISA kit

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Insulin Growth Factor	109.8 ng/mL Standard Deviation 63.2	75.0 ng/mL Standard Deviation 21.3

PRIMARY outcome

Timeframe: at the end of surgery after protamine reversal

The concentration of the IGF-1 was also measured by a quantitative ELISA kit

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Insulin Growth Factor	142.0 ng/mL Standard Deviation 67.1	82.1 ng/mL Standard Deviation 35.9

PRIMARY outcome

Timeframe: the first postoperative day

The concentration of the IGF-1 was also measured by a quantitative ELISA kit

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Insulin Growth Factor	108.6 ng/mL Standard Deviation 61.2	69.4 ng/mL Standard Deviation 35.4

SECONDARY outcome

Timeframe: immediately after surgery

after the surgery all the hemorrhage of patients was collected by suctioning and the exact amount of bleeding has been reported.

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Hemorrhage After Surgery	360.7 cc Standard Deviation 237.7	404.4 cc Standard Deviation 245.9

SECONDARY outcome

Timeframe: discharge 1 day

number of pack cell that was administered for the patient

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Blood Units Usage	0.5 units Standard Deviation 0.7	0.8 units Standard Deviation 0.9

SECONDARY outcome

Timeframe: discharge 1 day

period of time that the patient was on ventilator

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Ventilator Application	6.8 hr Standard Deviation 2.3	8.3 hr Standard Deviation 4.4

SECONDARY outcome

Timeframe: immediately after surgery

The serum level of Creatinine in the patients which is a measurement of the kidney function

Outcome measures

Measure	Vitamin D n=35 Participants 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 Participants 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Creatinine Level	.8 mg/dl Standard Deviation .05	.9 mg/dl Standard Deviation .04

Adverse Events

Vitamin D

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Control Group

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vitamin D n=35 participants at risk 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 participants at risk 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Nervous system disorders brain stroke	5.7% 2/35 • Number of events 3 • 2 weeks	5.7% 2/35 • Number of events 2 • 2 weeks
Cardiac disorders heart attack	2.9% 1/35 • Number of events 1 • 2 weeks	5.7% 2/35 • Number of events 2 • 2 weeks
Gastrointestinal disorders gastrointestinal bleeding	2.9% 1/35 • Number of events 2 • 2 weeks	2.9% 1/35 • Number of events 2 • 2 weeks

Other adverse events

Measure	Vitamin D n=35 participants at risk 35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units Vitamin D: Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery	Control Group n=35 participants at risk 35 patients that will receive placebo for 3 days and each day for 3 doses Placebo: Placebo
Vascular disorders DVT	5.7% 2/35 • Number of events 3 • 2 weeks	2.9% 1/35 • Number of events 2 • 2 weeks
Immune system disorders infection	14.3% 5/35 • Number of events 6 • 2 weeks	17.1% 6/35 • Number of events 7 • 2 weeks

Additional Information

Dr. ََAfshin Zarghi

Shahid Beheshti Medical School

Phone: 021-22439781

Email: Mpajouhesh@sbmu.ac.ir

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place