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  Comments & Suggestions  Suggest a topic  Clinical Trials...
 
 
 Clinical Trials 
 
 
torresinc
6 posts
Clinical Trials
Posted: 25 Oct 06 10:44 AM
  
Do you already have a nutrition Clinical Trials session?
If do, could you please point me out?

For instance: ClinicalTrials.gov web site has several of them, specially on Multivitamins.


 
 
host
10 posts
Re: Clinical Trials
Posted: 27 Nov 06 1:19 PM
  
We currently do not however, it is a very good idea. You can find some information on clinicals/results and activity by searching on "Clinical Trials" (use this link : http://www.npicenter.com/Search/Default.aspx?qs=clinical%20trials)
 
 
torresinc
6 posts
Re: Clinical Trials
Posted: 28 Nov 06 1:38 PM
  
Is it possible to establish a standard Clinical Trial for multivitamins? Since this industry is not yet regulated I think it is confusing to see multivitamins clinical trials using different formulations. In this case the results will be very different.

Personally I like the blended formulation suggested by the "Comparative Guide to Nutritional Supplements".

Since I am not a specialist, any nutritionist, biochemist or medical doctor here could answer this question?


All the best,


Ed Torres


 
 
len
1 posts
Re: Clinical Trials
Posted: 04 Dec 06 1:56 PM
  

Thank you for the post and question. I'd hope to encourage others to weigh in on this issue as well.

First of all, we're talking about a rather complicated issue.

The industry is regulated, although many have concerns both about the level of regulation and more often, the enfocement of existing regulations by FDA and FTC. Next, commerical products on the market do not have a 'standard' formulation and one would expect clinical trials to use 'available' product. This brings up the question of appropriate formulas and amounts of active, and expert opinion differs signficantly in this regard, hence the number of formulations. Further complicating this issue is the ability to measure 'endpoint' in a supplement clinical trial. The pharmaceutical model is usually targeted at a disease state (or absence) model, a challenge for many supplement products. The ingredient amount for a supplement product, targeted at a disease state, would typically be more than what might be available in a commercial product marketed as a supplement, and if the endpoint was a disease state, then the trial results would not be allowable for supplement marketing and education.

It is true that a series of clinical trials using one formulation would provide excellent data and some of these studies are currently underway, in some cases, sponsored by NIH. It is also true that more information about trial conditions (and materials) need to be both provided and understood. What is probably reasonable is that a formula:endpoint matrix could eventually be developed as a reference for future trials. Having said that, in their desire to present new and innovative products company-sponsored clinical trials would continue to use proprietary formulas for market edge, IP position and the ability to use speical science.

 
 
torresinc
6 posts
Re: Clinical Trials
Posted: 04 Dec 06 4:50 PM
  
Thank you very much Len!

Excelent answer! It helped me to understand a little more the difficulty for a multivitamins blended formulation for clinical trials. :)

All the best,

Ed Torres

 
  
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