No registrations found.
ID
Source
Brief title
Health condition
veisalgia (hangover)
Sponsors and support
1105 AZ Amsterdam
1105 AZ Amsterdam
Intervention
Outcome measures
Primary outcome
Main study parameter is the subjective feeling of well being as evaluated by the questionnaire.
Secondary outcome
Secondary parameter is the influence of alcohol intake on severity of veisalgia.
Background summary
Rationale: 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.
Study objective
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.
Study design
1 time point the morning after the intervention
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.
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1292 |
| NTR-old | NTR1339 |
| Other | : MEC 090/071 # 08.17.0405 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |