NCT00965822

Brief Summary

Parents with children aged 3-11 will participate in this study. About 500 children will take part in the study. We expect about half of those children will develop symptoms of a respiratory infection. Active participation in this study will last 14 days after a parent reports symptoms of a respiratory infection in a participant. Those children who do meet the study criteria of symptoms will then be randomly placed (like a flip of a coin) into one of 2 groups to take either COLD-FX® or placebo for 3 days. A placebo will look exactly like COLD-FX® but contains no active ingredients. The participant has an equal chance of being placed in either of the above groups. The study is double-blind, so neither the participant nor the study staff will know which study group the participant was placed in until the study is completed. If this information is needed in an emergency at any time throughout the study, it is quickly available from the sponsor. Participation in the study will be for 14 days after symptoms of a respiratory infection are reported to study staff. Your child will take the study product for 3 days, you will complete a daily diary, receive 4 phone calls and be seen for a final study visit to review the diary and complete a final health check of your child.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

2.6 years

First QC Date

August 25, 2009

Last Update Submit

August 30, 2012

Conditions

Upper Respiratory Tract Infections

Keywords

URTINatural Health Products

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to assess the efficacy of acute dosing of CVT-E002 in reducing the duration of URTI symptoms in children 3-11 years of age

    14 days

Secondary Outcomes (1)

  • To asses the efficacy of acute dosing of CVT-E002 in reducing: (1) symptom severity; (2) peak CARIFS scores and; (3) absenteeism for participant and/or parent/guardian.

    14 days

Study Arms (2)

1

ACTIVE COMPARATOR
Other: North American ginseng

2

PLACEBO COMPARATOR
Other: Placebo

Interventions

North American ginsengOTHER

3 day, once daily, dosing

Also known as: COLD-FX
1
PlaceboOTHER

3 day, once daily dosing

2

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy individuals of both genders aged years 3 - 11
  • Willing to adhere to the requirements of the protocol, including availability for follow-up visits
  • Parent/guardian willing and able to sign written consent

You may not qualify if:

  • Medical conditions:
  • Asthma requiring treatment in the last 3 months with oral steroids - prednisone greater than 10 mg/day
  • Received influenza vaccination for the winter season when the trial is run.
  • Active tuberculosis
  • Cystic fibrosis
  • Significant pulmonary disorders (chronic bronchitis, emphysema or other chronic respiratory illness)
  • Any ongoing allergen immunotherapy during study or for 6 months prior HIV/AIDS
  • Malignancy (under active observation or treatment)
  • Unstable cardiovascular disease (physician visit or hospitalization for unstable cardiovascular disease in the last 6 months)
  • Known renal abnormalities (serum creatinine known to be \> upper limit for age group)
  • Acute or active chronic liver disease
  • Diabetes
  • Neurological or psychiatric disease (progressive or currently under treatment)
  • Bleeding disorders
  • Major surgery in the last 6 months or planned surgery over the course of the study
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alberta Health Services

Edmonton, Alberta, T5N 4A3, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L4L2, Canada

Location

Canadian Center for Vaccinology, Dalhousie University

Halifax, Nova Scotia, B3K 6R8, Canada

Location

JDM Research

Toronto, Ontario, M4P 1P2, Canada

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

COLD-fX

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Shelly McNeil, FRCPC

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

CA(4)