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Back to the forum  Query: 2017-08-24 01:16 CEST (UTC+2h)
 
paulhurleyuk
Junior

NE UK,
2017-01-26 11:04

Posting: # 16995
Views: 995
 

 Students given 30g dose of Caffeine in Sports study [Off Topic]

Local to me, this story about a study in a sports science course of the effect of caffeine on exercise;

http://metro.co.uk/2017/01/25/students-left-fighting-for-life-after-taking-enough-caffeine-for-300-cups-of-coffee-6405671/

From the story; this trial had been conducted as part of the teaching course for many years, but had switched from tablets to caffeine powder. For this trial a member of staff calculated dosage using a mobile phone instead of a calculator, and the decimal place was misplaced, hence a dose of 30g, not 0.3g ! (Check out the pictures in the article comparing these two doses...)

Out of interest, Caffeine is released and available, so this isn't a clinical trial, but what regulations do apply ?

Paul.
Dr_Dan
Senior

2017-01-31 08:42

@ paulhurleyuk
Posting: # 16999
Views: 645
 

 Clinical trial? According to ICH-GCP definition yes!

» Out of interest, Caffeine is released and available, so this isn't a clinical trial, but what regulations do apply ?

Dear Paul
According to ICH-GCP a clinical trial is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining ist safety and/or efficacy.
IMHO the students were treated with a drug (coffeine as pure drug and not as cup of coffee) and nobody thought about the consequences neither for the students nor for themselves.

Kind regards and have a nice day
Dr_Dan
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