Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by:

innoVactiv Inc.

ClinicalTrials.gov Identifier:

NCT00906438

First received: May 20, 2009

Last updated: October 28, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	May 20, 2009
Last Updated Date	October 28, 2009
Start Date ^ICMJE	May 2009
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 20, 2009)	Occurrence of adverse events [ Time Frame: Baseline, 14 days, 28 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00906438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 20, 2009)	Serum IgA titers [ Time Frame: Baseline, 14 days, 28 days ] [ Designated as safety issue: No ] Salivary IgA titers [ Time Frame: Baseline, 14 days, 28 days ] [ Designated as safety issue: No ]
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	Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects
Official Title ^ICMJE	Effects of 2006-RD-05 on Salivary and Serum IgA Levels in Healthy Subjects
Brief Summary	It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In addition, this trial will aim to determine if this intake is able ot improve serum and salivary IgA synthesis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Dietary Supplement: 2006-RD-05 300 mg daily, once a day for 28 consecutive days Dietary Supplement: Placebo Capsule similar in shape, weight and color from active, once a day for 28 consecutive days
Study Arm (s)	Placebo Comparator: Control Intervention: Dietary Supplement: Placebo Experimental: Treated Intervention: Dietary Supplement: 2006-RD-05
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
Estimated Enrollment ^ICMJE	50
Completion Date	October 2009
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men or women aged 18 - 60 In good health BMI between 20 and 30 kg/m2 Non-smoking Exclusion Criteria: Allergic to study drug Use of immune-modulating drugs Uncontrolled hypertension (Systolic > 140 or diastolic > 90) Women of childbearing age not using proper contraception, that is pregnant or breastfeeding
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00906438
Other Study ID Numbers ^ICMJE	2006-RD-05-CLN1
Has Data Monitoring Committee	Not Provided
Responsible Party	Scientific Director, Health & Nutrition, innoVactiv inc.
Study Sponsor ^ICMJE	innoVactiv Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	innoVactiv Inc.
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top