Effects of 2006-RD-05 on Salivary and Serum Immunoglobuli... | NCT00906438

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

NCT00906438

Sponsor

innoVactiv Inc.

Status

Completed

Last Update Posted

Oct 29, 2009Estimated

Enrollment

50Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

2006-RD-05
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

May 20, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2009

Last Update Posted Date

Oct 29, 2009Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator		Dietary Supplement: Placebo
Treated	Experimental		Dietary Supplement: 2006-RD-05

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2006-RD-05	Dietary Supplement	300 mg daily, once a day for 28 consecutive days	Treated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of adverse events		Baseline, 14 days, 28 days

Secondary Outcomes

Measure	Description	Time Frame
Serum IgA titers		Baseline, 14 days, 28 days
Salivary IgA titers		Baseline, 14 days, 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)		Québec	Quebec	G1K 7P4	Canada