Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children
A Double-blind, Randomized, Controlled Study to Compare the Effects of Syrup With EpiCor and Vitamin C to Syrup With Vitamin C Alone on the Common Cold or Influenza in Generally Healthy Children
1 other identifier
interventional
221
1 country
21
Brief Summary
The purpose of the clinical study is to evaluate efficacy of regular daily, 12 weeks, consumption of EpiCor syrup containing EpiCor and vitamin C in non-vaccinated children 1-6 years old on preventing episodes of the common cold and flu as well as on the severity of symptoms of the common cold and flu in case of their occurrence. Additionally, the study aims to assess the effect of EpiCor on the use of prescription drugs and changes of a selected biochemical marker. This is a double-blind, randomized, controlled multi-center clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2019
CompletedFirst Submitted
Initial submission to the registry
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 17, 2019
CompletedSeptember 17, 2019
September 1, 2019
1.3 years
September 16, 2019
September 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of the common cold an influenza
Daily Study Dairy
Number of episodes of common cold and/or influenza during 12 weeks of product consumption
Secondary Outcomes (5)
Duration of the common cold and influenza
Duration of common cold and influenza during 12 weeks of product consumption
Severity of common cold and influenza
Severity of common cold and influenza symptoms during the 12 weeks of product consumption
Use of prescription drugs
Number of prescription drugs during the 12 weeks of product consumption
Change of salivary secretory immunoglobulin A (sIgA) levels
Change of salivary sIgA levels after 6 and 12 weeks of product consumption
Safety of investigational product consumption
Safety of investigational product consumption during the 12 weeks study period
Study Arms (2)
EpiCor and Vitamin C
EXPERIMENTALEpiCor (90mg/5ml) and Vitamin C (25mg/5ml) given at dose of 5ml to children 1-2 years old, 7.5ml to children 3-4 years old and 10ml to children 5-6 years old
Vitamin C
ACTIVE COMPARATORVitamin C (25mg/5ml) given at dose of 5ml to children 1-2 years old, 7.5ml to children 3-4 years old and 10ml to children 5-6 years old
Interventions
Eligibility Criteria
You may qualify if:
- Generally healthy male and female children
- years of age
- Children attending kindergarten
- Signed informed consent by child's parent or legal guardian and willingness to participate in all study activities
You may not qualify if:
- Immune dysfunction and/or taking an immunosuppressive medication
- Child who has received flu vaccination
- Child who is still breastfed
- Child taking other food supplements
- Unable or unwilling to comply with study protocol, including ingesting investigational product, and completing subject dairy
- Current participation in another clinical study
- Severe co-morbidity or concomitant disease
- Concurrent disease or condition, which in the judgment of the investigator, would make the child inappropriate for participation in the study
- High risk of complications from influenza
- Allergies to yeast-derived products
- Severe environmental allergies requiring medication or need for allergy shots
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cargilllead
- Clinres Farmacija d.o.o.collaborator
- PharmaLinea d.o.o.collaborator
- Diagnostic Laboratory Medicare PLUS d.o.o.collaborator
- Embria Health Sciencescollaborator
Study Sites (21)
Zdravstveni dom Domzale
Domžale, 1230, Slovenia
Zasebna pediatricna ordinacija Ivan Kauzlaric
Ilirska Bistrica, 6250, Slovenia
ZD Ivancna Gorica
Ivančna Gorica, 1295, Slovenia
Zdravstveni dom Kocevje
Kočevje, 1330, Slovenia
Ambulanta za otroke in solarje Pedenjped d.o.o.
Lenart v Slov. Goricah, 2230, Slovenia
Zasebna ambulanta Moj pediater Matjaz Homsak
Lenart v Slov. Goricah, 2230, Slovenia
Zasebna otroska in solska ambulanta Mojca Ivankovic Kacjan
Lenart v Slov. Goricah, 2230, Slovenia
Clinres Farmacija d.o.o.
Ljubljana, 1000, Slovenia
Zdravstveni dom Ljubljana
Ljubljana, 1000, Slovenia
Zasebna pediatricna ambulanta Vesna Lazar Daneu
Lucija, 6320, Slovenia
Pediatrinja Suzana Skorjanc Antolic Zdravstvena Dejavnost d.o.o.
Maribor, 2000, Slovenia
Zdravstveni dom Dr. Adolfa Droca Maribor
Maribor, 2000, Slovenia
Zdravstveni dom Dr. Adolfa Drolca Maribor
Maribor, 2000, Slovenia
Zasebna pediatricna ambulanta Damir Dabranin
Slovenske Konjice, 3210, Slovenia
Zdravstveni dom Nova Gorica
Šempeter pri Gorici, 5290, Slovenia
Pediatrija Sentilj
Šentilj v Slovenskih goricah, 2212, Slovenia
Zdravstveni dom Tolmin
Tolmin, 5220, Slovenia
Zadravstveni dom Trebnje
Trebnje, 8210, Slovenia
Zdravstveni dom Trebnje
Trebnje, 8210, Slovenia
Zasebna Otroska in Solska Ordinacija
Tržič, 4290, Slovenia
Zdravstveni dom Zagorje
Zagorje ob Savi, Slovenia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alojz Ihan
University of Ljubljana
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2019
First Posted
September 17, 2019
Study Start
December 22, 2017
Primary Completion
March 28, 2019
Study Completion
March 28, 2019
Last Updated
September 17, 2019
Record last verified: 2019-09