Status:
COMPLETED
Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children
Lead Sponsor:
Cargill
Collaborating Sponsors:
Clinres Farmacija d.o.o.
PharmaLinea d.o.o.
Conditions:
Signs and Symptoms, Respiratory
Eligibility:
All Genders
1-6 years
Phase:
NA
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...
Detailed Description
This is a double-blind, randomized, controlled multi-center clinical trial aiming to evaluate the effects of daily consumption of EpiCor with vitamin C, primarily on the incidence and, secondary, on t...
Eligibility Criteria
Inclusion
- Generally healthy male and female children
- 1-6 years of age
- Children attending kindergarten
- Signed informed consent by child's parent or legal guardian and willingness to participate in all study activities
Exclusion
- 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
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT04093206
Start Date
December 22 2017
End Date
March 28 2019
Last Update
September 17 2019
Active Locations (21)
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1
Zdravstveni dom Domzale
Domžale, Slovenia, 1230
2
Zasebna pediatricna ordinacija Ivan Kauzlaric
Ilirska Bistrica, Slovenia, 6250
3
ZD Ivancna Gorica
Ivančna Gorica, Slovenia, 1295
4
Zdravstveni dom Kocevje
Kočevje, Slovenia, 1330