NCT06155981

Brief Summary

The purpose of this study is to determine the effect of coke zero consumption by night-call staffs on inpatient admission and mortality, and total sleep duration during the night-call duty. Coke Zero is a soft drink that is widely popular within the medical community, carrying the meaning of "zero", which to some, signifies the minimal level of morbidity and mortality that will occupy the on-call the night staffs.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 18, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

23 days

First QC Date

November 18, 2023

Last Update Submit

February 17, 2024

Conditions

Keywords

Coke ZeroNight-call StaffsInpatient AdmissionInpatient CourseInpatient Mortality

Outcome Measures

Primary Outcomes (3)

  • Inpatient Mortality

    For patients assigned under the designated night-call doctor's care

    The designated night-call doctor's shift from 5PM to 8AM the next day

  • Inpatient general ward admission

    For patients assigned under the designated night-call doctor's care

    The designated night-call doctor's shift from 5PM to 8AM the next day

  • Inpatient High Dependency/Intensive Care Unit Admission

    For patients assigned under the designated night-call doctor's care

    The designated night-call doctor's shift from 5PM to 8AM the next day

Secondary Outcomes (4)

  • Hours of sleep during the night-call

    The designated night-call doctor's shift from 5PM to 8AM the next day

  • Hours of shift during the night-call

    The designated night-call doctor's shift from 5PM to 8AM the next day

  • Number of steps walked by the night-call staff during the night-call

    The designated night-call doctor's shift from 5PM to 8AM the next day

  • Level of alertness of the night-call staff after the night-call

    The designated night-call doctor's shift from 5PM to 8AM the next day

Study Arms (2)

Coke Zero Arm

EXPERIMENTAL

The participant will be given a Coke Zero before each night-call duty for consumption.

Other: Coke Zero

Coke Arm

ACTIVE COMPARATOR

The participant will be given a Coke before each night-call duty for consumption.

Other: Coke

Interventions

Coca-Cola Zero Sugar drink will be given.

Coke Zero Arm
CokeOTHER

Coca-Cola drink will be given.

Coke Arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Doctors on the night-call roster at Singapore General Hospital

You may not qualify if:

  • Other allied health professionals or medical students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (1)

  • Tan MH, Lee Z, Ng B, Sim ES, Chua YY, Tien M, Ooi CJ. The Tao of bao: a randomised controlled trial examining the effect of steamed bun consumption on night-call inpatient course and mortality. Ann Acad Med Singap. 2008 Mar;37(3):255-3.

    PMID: 18392313BACKGROUND

MeSH Terms

Interventions

Coke

Intervention Hierarchy (Ancestors)

CoalFossil FuelsComplex MixturesEnergy-Generating ResourcesEnvironmentEnvironment and Public Health

Study Officials

  • Yu Heng Kwan, MD, PhD

    SingHealth Internal Medicine Residency

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of the type of drink they receive.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two groups of night-call staffs will be receiving different interventions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 18, 2023

First Posted

December 5, 2023

Study Start

January 10, 2024

Primary Completion

February 2, 2024

Study Completion

December 31, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share IPD to other researchers.

Locations