Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial

This study has been completed.

Sponsor:

Information provided by:

Kyberg Vital GmbH

ClinicalTrials.gov Identifier:

NCT01414335

First received: August 9, 2011

Last updated: August 10, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 9, 2011
Last Updated Date	August 10, 2011
Start Date ^ICMJE	October 2009
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 10, 2011)	outcome of efficacy [ Time Frame: 3 month treatment ] [ Designated as safety issue: No ] For each study day,participants recorded in a diary rectal temperature, symptoms of sneezing, blocked nose or streaming eyes, whether they had problems to swollow and whether they had headache or pain in arms or legs.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01414335 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 10, 2011)	outcome of efficacy [ Time Frame: 3 month treatment ] [ Designated as safety issue: No ] Secondary outcome variables: feel the patient fit and able-bodied.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial
Official Title ^ICMJE	Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Randomized Completely Masked Trial
Brief Summary	The purpose of this study is to investigate the effectiveness of a dietary supplement with high dosage of amino acids and vitamins in the treatment of acute and chronic infection of pharyngeal area known as common cold. T
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo
Intervention ^ICMJE	Dietary Supplement: amino acid composition one single pouch (13g) of amino acid mixture and vitamins diluted into 200 ml of still water. This solution was daily oral taken after a meal. Other Name: Brand name: aminoplus immun Other: Placebo placebo contained no amino acids and vitamins and was identical in appearance and solution properties. Other Names: remedy placebo
Study Arm (s)	Placebo Comparator: placebo Intervention: Other: Placebo Active Comparator: amino acid composition Intervention: Dietary Supplement: amino acid composition
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	145
Completion Date	September 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: men and women with at least two episodes of common cold and infection of ear, nose and pharyngeal area. Exclusion Criteria: people with severe infection like pneumonia, patients expecting an in-patient treatment during the trial, pregnant or breast feeding and people not able to understand the procedure of the treatment
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01414335
Other Study ID Numbers ^ICMJE	Kyb10/09
Has Data Monitoring Committee	No
Responsible Party	Sponsor: Kyberg Vital GmbH
Study Sponsor ^ICMJE	Kyberg Vital GmbH
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kyberg Vital GmbH
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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