Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes in Cardiac Surgery Patients.

• Sponsor: Shahid Beheshti University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05402826
• Collaborator: Kerman University of Medical Sciences (Other)
• Enrollment: 74
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 18.5

Study Details

Study Description

Brief Summary

Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. Using antioxidants during perioperative period may help improve this condition. Vitamin E and zinc have antioxidant effects. In this study, the effects of oral co-administration of zinc and vitamin E supplements on short-term postoperative outcomes in cardiac surgery patients will be investigated.

Condition or Disease	Intervention/Treatment	Phase
Heart Surgery	Dietary Supplement: Oral zinc + vitamin E; Dietary Supplement: Placebo	N/A

Detailed Description

Cardiac surgery is a life-saving invasive procedure that may often be associated with significant postoperative complications. Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. This is a post-ischemic complication that occurs when blood circulation is restored and causes inflammation and oxidative damage. Cardiac surgery with reperfusion injury can adversely affect the prognosis. Thus, reducing the extend of reperfusion injury and its associated pathways can be considered an important clinical issue. Reducing oxidative stress and inflammation may play an important role in the outcomes of heart surgery. Using antioxidants in pre or post surgery may help improve this condition. Vitamin E is a well-known fat-soluble antioxidant that prevents lipid peroxidation. Zinc has several roles including antioxidant effects. Zinc acts as a cofactor for important enzymes that contribute to the proper functioning of the antioxidant defense system. In addition, the mineral is involved in reducing free radicals by inducing metallothionein synthesis and circulating zinc concentration decreases significantly after surgery. In this study, the effects of oral co-administration of zinc and vitamin E supplements shortly before and after surgery on short-term postoperative outcomes, plasma concentrations of biomarkers of oxidative stress and inflammation in patients will be investigated.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Co-administration of Zinc and Vitamin E Oral Supplements on Short-term Postoperative Outcomes and Plasma Concentrations of Oxidative Stress Biomarkers in Cardiac Surgery Patients
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Patients will receive placebo pills.	Dietary Supplement: Placebo; Patients in the placebo group will receive placebo pills before and after surgery.
Active Comparator: Zinc+vitamin E supplements Patients will receive zinc tablets plus alpha-tocopherol.	Dietary Supplement: Oral zinc + vitamin E; In the zinc + vitamin E supplementation group, patients will receive a cumulative dose of 120 mg of oral zinc supplementation plus a cumulative dose of 1200 IU of oral vitamin E before surgery. After surgery, from the second day to the end of the hospital stay, patients receive 30 mg of zinc supplement plus 200 units of vitamin E per day.

Outcome Measures

Primary Outcome Measures

1. ICU LOS [Through study completion, an average of 5 days]

   Duration of patients' stay in the intensive care unit

2. Post surgery hospital LOS [Through study completion, an average of 10 days]

   Duration of patients' stay in the hospital

Secondary Outcome Measures

1. The sequential organ failure assessment score [On the third day after surgery]

   Higher scores mean a worse outcome.

2. Plasma superoxide dismutase activity [up to 3 days after surgery]

   Plasma superoxide dismutase activity in patients studied before surgery and three days after surgery

3. Plasma total antioxidant [up to 3 days after surgery]

   Plasma total antioxidant capacity in patients studied before surgery and three days after surgery

4. Plasma CRP [up to 3 days after surgery]

   Plasma C-reactive protein level in patients studied before surgery and three days after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are candidates for open heart surgery (coronary artery bypass grafting)

Exclusion Criteria:

• Frequent use of multivitamin, zinc, vitamin E, vitamin C, omega-3 supplements over the past month

• Active cancer, chronic rheumatic disease, ESRD, liver cirrhosis, severe infection (WBC> 12000 mm3) before surgery

• Continued use of corticosteroids or NSAIDs for two weeks prior to admission (except A.S.A)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shahid Beheshti University of Medical Sciences	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University
• Kerman University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Javad Nasrollahzadeh, Associate Professor, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT05402826
• Other Study ID Numbers: 30285
• First Posted: Jun 2, 2022
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vitamin E

Study Results

No Results Posted as of Jun 2, 2022