Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children
Condition: Signs and Symptoms, Respiratory
MeSH terms: Common Cold; Signs and Symptoms, Respiratory
Study type: Interventional

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.
    

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 the duration and severity of the common cold and influenza in children,
      compared to the effects of daily consumption of vitamin C alone. Healthy children aged 1-6
      years old are included in the study after parents have provided informed consent for study
      participation. Children are divided in 3 age groups (1-2 year old, 3-4 years old, 5-6 years
      old) and randomized in one of the two groups (intervention or control) at a 1:1 ratio.
      Children eligible for participation are included in the study for 12 weeks. During this
      period, they visit the investigational center 3 times. During visit 1 (day 0) caregivers get
      familiarized with the purpose, course and procedures of the trial, provide written informed
      consent upon which investigator assesses child's suitability for participation and, for
      eligible children, a study participant number is provided and a randomization number is
      assigned; in addition, the investigator collects demographic information, data on vital
      signs, medical history, collects a sample for determination of salivary secretory
      immunoglobulin A (sIgA), provides caregivers with a Study Dairy and clear instructions
      regarding completion, consumption, storage and return of unused syrup, taking medication and
      other food supplements during the study, monitoring adverse events and measures to be taken
      in the event of serious adverse events, determines the daily dose of syrup to be taken based
      on child's age, supplies the caregiver with enough syrup and sets a date for next visit.
      Between visits, children take a prescribed dose of syrup once daily. Six weeks (visit 2) and
      12 weeks (visit 3) after the first visit, children and caregivers visit the investigational
      center again. During these 2 visits, the investigator collects data on vital signs, reviews
      concomitant medication and the taking of other food supplements, collects sample for
      determination of salivary SIgA, reviews the Study Dairy, supplies the caregiver with new
      syrup and provides the same clear instructions as in visit 1. Caregivers are asked to
      complete the Study Dairy on daily basis and, each time a caregiver marks that a symptom is
      present, the Investigator receives a notification and reviews the symptoms and consequently
      confirms the episode of a common cold/flu. The Canadian Acute Respiratory Illness and Flu
      Scale (CARIFS) is used to assess the severity of symptoms of the common cold and flu in
      participating children and, in case of occurrence of cold/flu symptoms, caregivers are asked
      to complete the form twice a day for the first seven days, once on day 10 and once on day 14.
    

Intervention name(s): EpiCor and Vitamin C; Vitamin C
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One daily dose; One daily dose
Intervention MeSH terms: Vitamins; Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other