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HORSE trial


- candidate number3433
- NTR NumberNTR1339
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jun-2008
- Secondary IDsMEC 090/071 # 08.17.0405 
- Public TitleHORSE trial
- Scientific TitleHangover prevention by the Oral Rehydration Solution Effect
- ACRONYMHORSE
- hypothesisThe correlation between alcohol intake and dehydration is observed in several studies. ORS, Oral Rehydration Solution is a reliable treatment for dehydration. The link between ORS and relieve of veisalgia has been suggested by several sources, although evidence was never generated.
- Healt Condition(s) or Problem(s) studiedVeisalgia, Alcohol, Oral Rehydration Solution (ORS)
- Inclusion criteria1. Age 18 65
2. Signed informed consent when sober (breathalyzer promillage is < 0.5)
3. Participant has had hang over before and recognizes the symptoms headache, nausea and a diminished feeling of general well-being
4. Participant has access to the internet shortly after waking up
- Exclusion criteria1. Pregnancy
2. Alcohol promillage by breathalyzer when intake of placebo or ORS > 2.0
3. Participant has inability to comply with protocol or study procedures (for example, an inability to swallow fluids)
4. Participant is at this moment under treatment by medical specialist
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-mrt-2008
- planned closingdate1-jan-2009
- Target number of participants200
- InterventionsVolunteers are asked to participate prior to engaging in a social event. When leaving the event, participants will consume ORS or placebo. The next day, all subjects are asked to fill in a questionnaire concerning veisalgia, an adapted version of the Acute Hang Over Scale.
- Primary outcomeMain study parameter is the subjective feeling of well being as evaluated by the questionnaire.
- Secondary outcomeSecondary parameter is the influence of alcohol intake on severity of veisalgia.
- Timepoints1 time point the morning after the intervention
- Trial web sitewww.trialburo.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDhr. L. Vermeulen
- CONTACT for SCIENTIFIC QUERIESDhr. L. Vermeulen
- Sponsor/Initiator Academic Medical Center (AMC), Department of Experimental Oncology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Experimental Oncology
- PublicationsN/A
- Brief summaryRationale: Development of veisalgia, or hangover, is a frequent event after a night of drinking. Hangovers are typically characterized by headache, nausea and diminished feeling of general well-being. Next to personal disadvantages, it has been suggested that the economical consequences of hangovers are severe. Several studies investigated possible pathogenic mechanisms for hangovers. Of these mechanisms, dehydration is an accepted cause for a hangover. Alcohol inhibits release of anti-diuretic hormone what leads to dehydration. The correlation between alcohol intake and dehydration is observed in several studies. ORS, Oral Rehydration Solution is a reliable treatment for dehydration. The link between ORS and relieve of veisalgia has been suggested by several sources, although evidence was never generated.
Objective: This trial should provide evidence for reduced symptoms of veisalgia after preventive intake of ORS (Oral Rehydration Solution) after drinking alcoholic beverages.
Study design: Randomized placebo controlled double-blind intervention study.
Study population: 200 healthy volunteers age 18 65.
Intervention: Volunteers are asked to participate prior to engaging in a social event. When leaving the event, participants will consume ORS or placebo. The next day, all subjects are asked to fill in a questionnaire concerning veisalgia, an adapted version of the Acute Hang Over Scale.
Main study parameters/endpoints: Main study parameter is the subjective feeling of well being as evaluated by the questionnaire. Secondary parameter is the influence of alcohol intake on severity of veisalgia.
- Main changes (audit trail)
- RECORD6-jun-2008 - 28-jan-2011


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