MortalityNCT06155981
Coca-Cola Zero (®) Consumption on Night-call Inpatient Course and Mortality
A study testing Coke Zero and Coke in people with Mortality, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mortality
- What is being tested?
- Coke Zero and Coke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Jan 2024to 31 Dec 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Doctors on the night-call roster at Singapore General Hospital
Who cannot join
- Other allied health professionals or medical students
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coke Zero for the Zero: A Study Examining the Effect of Coke Zero Consumption on Night Call Inpatient Course and Mortality
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.
Read the detailed description
Previous studies have demonstrated that superstitions among the medical community have been prevalent and staffs regularly engaged in conforming to the superstitions because of their associations with workload, inpatient admissions and mortality. As such, the current study aims to evaluate whether the consumption of Coke Zero has an effects on patient admissions and mortality and the eventfulness of the night-call duties.
- Conditions
- Mortality
- Being tested
- Coke Zero, Coke
- Keywords
- Coke Zero, Night-call Staffs, Inpatient Admission, Inpatient Course, Inpatient Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coke ZeroOther
Coca-Cola Zero Sugar drink will be given.
CokeOther
Coca-Cola drink will be given.
| Study group | Role | What they receive |
|---|---|---|
| Coke Zero Arm | Experimental | The participant will be given a Coke Zero before each night-call duty for consumption. Receives: Other: Coke Zero |
| Coke Arm | Active comparator | The participant will be given a Coke before each night-call duty for consumption. Receives: Other: Coke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient Mortality
For patients assigned under the designated night-call doctor's care
Measured: 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
Measured: 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
Measured: The designated night-call doctor's shift from 5PM to 8AM the next day
Secondary outcomes (4)
Hours of sleep during the night-call
For the designated night-call doctor's care
Measured: The designated night-call doctor's shift from 5PM to 8AM the next day
Hours of shift during the night-call
For the designated night-call doctor's care
Measured: 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
For the designated night-call doctor's care
Measured: 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
Measured using the Karolinska Sleepiness Scale and the Epworth Sleepiness Scale
Measured: The designated night-call doctor's shift from 5PM to 8AM the next day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start10 Jan 2024
- Primary completion2 Feb 2024
- Study completion31 Dec 2024 (estimated)
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 MortalityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of night-call staffs will be receiving different interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwan Yu Heng, Duke-NUS Graduate Medical School
- Investigators
- Yu Heng Kwan, MD, PhD, Principal investigator, SingHealth Internal Medicine Residency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155981
- Sponsor's protocol ID
- DukeNushssrkyh-01
- Status last verified
- Feb 2024
- First submitted
- 18 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share IPD to other researchers.
Publications
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.
PubMed 18392313
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coke Zero for the Zero: A Study Examining the Effect of Coke Zero Consumption on Night Call Inpatient Course and Mortality
- ClinicalTrials.gov ID
- NCT06155981
- Acronym / sponsor ID
- DukeNushssrkyh-01
- Conditions
- Mortality
- Keywords
- Coke Zero, Night-call Staffs, Inpatient Admission, Inpatient Course, Inpatient Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Dec 2023 (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.
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.
Detailed description
Previous studies have demonstrated that superstitions among the medical community have been prevalent and staffs regularly engaged in conforming to the superstitions because of their associations with workload, inpatient admissions and mortality. As such, the current study aims to evaluate whether the consumption of Coke Zero has an effects on patient admissions and mortality and the eventfulness of the night-call duties.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups of night-call staffs will be receiving different interventions.
| Arm | Type | Receives |
|---|---|---|
| Coke Zero Arm | Experimental | Other: Coke ZeroThe participant will be given a Coke Zero before each night-call duty for consumption. |
| Coke Arm | Active comparator | Other: CokeThe participant will be given a Coke before each night-call duty for consumption. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Doctors on the night-call roster at Singapore General Hospital
Key exclusion criteria (1 listed)
- Other allied health professionals or medical students
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 |
|---|---|---|
| Coke ZeroCoca-Cola Zero Sugar drink will be given. | Other | Coke Zero Arm |
| CokeCoca-Cola drink will be given. | Other | Coke Arm |
Primary outcome
Inpatient Mortality
Time frame: The designated night-call doctor's shift from 5PM to 8AM the next day
For patients assigned under the designated night-call doctor's care
Inpatient general ward admission
Time frame: The designated night-call doctor's shift from 5PM to 8AM the next day
For patients assigned under the designated night-call doctor's care
Inpatient High Dependency/Intensive Care Unit Admission
Time frame: The designated night-call doctor's shift from 5PM to 8AM the next day
For patients assigned under the designated night-call doctor's care
4 secondary outcomes
Hours of sleep during the night-call
Time frame: The designated night-call doctor's shift from 5PM to 8AM the next day
Hours of shift during the night-call
Time frame: 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
Time frame: 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
Time frame: The designated night-call doctor's shift from 5PM to 8AM the next day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 18392313Tan 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.
- Individual participant dataSharing planned: No. There is currently no plan to share IPD to other researchers.
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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.
Yu Heng Kwan, MD, PhD principal investigator
SingHealth Internal Medicine Residency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coke Zero and Coke in people with Mortality, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 Singapore. 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. 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?
Results are not available in the source record.
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?
Inpatient Mortality (time frame: The designated night-call doctor's shift from 5PM to 8AM the next day). The study lists 3 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 NCT06155981, 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 20 Feb 2024.