Heart SurgeryNCT05402826
Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes in Cardiac Surgery Patients.
A study testing Oral zinc + vitamin E in people with Heart Surgery, run by Shahid Beheshti University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Surgery
- What is being tested?
- Oral zinc + vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteIran
- Study dates
- 6 Jun 2022to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are candidates for open heart surgery (coronary artery bypass grafting)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Heart Surgery
- Being tested
- Oral zinc + vitamin E, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral zinc + vitamin EDietary supplement
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.
PlaceboDietary supplement
Patients in the placebo group will receive placebo pills before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive placebo pills. Receives: Dietary Supplement: Placebo |
| Zinc+vitamin E supplements | Active comparator | Patients will receive zinc tablets plus alpha-tocopherol. Receives: Dietary Supplement: Oral zinc + vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU LOS
Duration of patients' stay in the intensive care unit
Measured: Through study completion, an average of 5 days
Post surgery hospital LOS
Duration of patients' stay in the hospital
Measured: Through study completion, an average of 10 days
Secondary outcomes (4)
The sequential organ failure assessment score
Higher scores mean a worse outcome.
Measured: On the third day after surgery
Plasma superoxide dismutase activity
Plasma superoxide dismutase activity in patients studied before surgery and three days after surgery
Measured: up to 3 days after surgery
Plasma total antioxidant
Plasma total antioxidant capacity in patients studied before surgery and three days after surgery
Measured: up to 3 days after surgery
Plasma CRP
Plasma C-reactive protein level in patients studied before surgery and three days after surgery
Measured: up to 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start6 Jun 2022
- Primary completion26 Dec 2022
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Collaborators
- Kerman University of Medical Sciences
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402826
- Sponsor's protocol ID
- 30285
- Status last verified
- Jan 2023
- First submitted
- 21 May 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Makiabadi E, Nakhaeizadeh R, Soleimani M, Nasrollahzadeh J. Effects of perioperative vitamin E and zinc co-supplementation on systemic inflammation and length of stay following coronary artery bypass graft surgery: a randomized controlled trial. Eur J Clin Nutr. 2024 Feb;78(2):120-127. doi: 10.1038/s41430-023-01356-x. Epub 2023 Oct 27.
PubMed 37891226
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05402826
- Acronym / sponsor ID
- 30285
- Conditions
- Heart Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Collaborators
- Kerman University of Medical Sciences
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients will receive placebo pills. |
| Zinc+vitamin E supplements | Active comparator | Dietary Supplement: Oral zinc + vitamin EPatients will receive zinc tablets plus alpha-tocopherol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are candidates for open heart surgery (coronary artery bypass grafting)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral zinc + vitamin EIn 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. | Dietary supplement | Zinc+vitamin E supplements |
| PlaceboPatients in the placebo group will receive placebo pills before and after surgery. | Dietary supplement | Placebo |
Primary outcome
ICU LOS
Time frame: Through study completion, an average of 5 days
Duration of patients' stay in the intensive care unit
Post surgery hospital LOS
Time frame: Through study completion, an average of 10 days
Duration of patients' stay in the hospital
4 secondary outcomes
The sequential organ failure assessment score
Time frame: On the third day after surgery
Plasma superoxide dismutase activity
Time frame: up to 3 days after surgery
Plasma total antioxidant
Time frame: up to 3 days after surgery
Plasma CRP
Time frame: up to 3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 37891226Makiabadi E, Nakhaeizadeh R, Soleimani M, Nasrollahzadeh J. Effects of perioperative vitamin E and zinc co-supplementation on systemic inflammation and length of stay following coronary artery bypass graft surgery: a randomized controlled trial. Eur J Clin Nutr. 2024 Feb;78(2):120-127. doi: 10.1038/s41430-023-01356-x. Epub 2023 Oct 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral zinc + vitamin E in people with Heart Surgery, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU LOS (time frame: Through study completion, an average of 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.