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

NCT00906438 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-10-29

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • innoVactiv Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-08-31
Completion
2009-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00906438 on ClinicalTrials.gov