NCT05402826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2023

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

May 21, 2022

Last Update Submit

January 4, 2023

Conditions

Heart Surgery

Outcome Measures

Primary Outcomes (2)

  • ICU LOS

    Duration of patients' stay in the intensive care unit

    Through study completion, an average of 5 days

  • Post surgery hospital LOS

    Duration of patients' stay in the hospital

    Through study completion, an average of 10 days

Secondary Outcomes (4)

  • The sequential organ failure assessment score

    On the third day after surgery

  • Plasma superoxide dismutase activity

    up to 3 days after surgery

  • Plasma total antioxidant

    up to 3 days after surgery

  • Plasma CRP

    up to 3 days after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will receive placebo pills.

Dietary Supplement: Placebo

Zinc+vitamin E supplements

ACTIVE COMPARATOR

Patients will receive zinc tablets plus alpha-tocopherol.

Dietary Supplement: Oral zinc + vitamin E

Interventions

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.

Zinc+vitamin E supplements
PlaceboDIETARY_SUPPLEMENT

Patients in the placebo group will receive placebo pills before and after surgery.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shafa Hospital, Kerman University of Medical Sciences

Kerman, Iran

Location

Related Publications (1)

  • 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.

    PMID: 37891226DERIVED

MeSH Terms

Interventions

ZincVitamin E

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 21, 2022

First Posted

June 2, 2022

Study Start

June 6, 2022

Primary Completion

December 26, 2022

Study Completion

January 3, 2023

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)