Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children
NCT04093206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221
Last updated 2019-09-17
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.
Conditions
- Signs and Symptoms, Respiratory
Interventions
- DIETARY_SUPPLEMENT
-
EpiCor and Vitamin C
One daily dose
- DIETARY_SUPPLEMENT
-
Vitamin C
One daily dose
Sponsors & Collaborators
-
Clinres Farmacija d.o.o.
collaborator INDUSTRY -
PharmaLinea d.o.o.
collaborator UNKNOWN -
Diagnostic Laboratory Medicare PLUS d.o.o.
collaborator UNKNOWN -
Embria Health Sciences
collaborator UNKNOWN -
Cargill
lead INDUSTRY
Principal Investigators
-
Alojz Ihan · University of Ljubljana
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-12-22
- Primary Completion
- 2019-03-28
- Completion
- 2019-03-28
Countries
- Slovenia
Study Locations
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