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

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.

Study Overview

• Status: Completed
• Conditions: Signs and Symptoms, Respiratory
• Intervention / Treatment: Dietary supplement: EpiCor and Vitamin C; Dietary supplement: Vitamin C

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.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Domžale, Slovenia, 1230
    • Zdravstveni dom Domzale
  • Ilirska Bistrica, Slovenia, 6250
    • Zasebna pediatricna ordinacija Ivan Kauzlaric
  • Ivančna Gorica, Slovenia, 1295
    • ZD Ivancna Gorica
  • Kocevje, Slovenia, 1330
    • Zdravstveni dom Kocevje
  • Lenart V Slov. Goricah, Slovenia, 2230
    • Zasebna ambulanta Moj pediater Matjaz Homsak
  • Lenart v Slov Goricah, Slovenia, 2230
    • Ambulanta za otroke in solarje Pedenjped d.o.o.
  • Lenart v Slov Goricah, Slovenia, 2230
    • Zasebna otroska in solska ambulanta Mojca Ivankovic Kacjan
  • Ljubljana, Slovenia, 1000
    • Clinres Farmacija d.o.o.
  • Ljubljana, Slovenia, 1000
    • Zdravstveni Dom Ljubljana
  • Lucija, Slovenia, 6320
    • Zasebna pediatricna ambulanta Vesna Lazar Daneu
  • Maribor, Slovenia, 2000
    • Pediatrinja Suzana Skorjanc Antolic Zdravstvena Dejavnost d.o.o.
  • Maribor, Slovenia, 2000
    • Zdravstveni dom Dr. Adolfa Droca Maribor
  • Maribor, Slovenia, 2000
    • Zdravstveni Dom Dr. Adolfa Drolca Maribor
  • Sempeter pri Gorici, Slovenia, 5290
    • Zdravstveni dom Nova Gorica
  • Sentilj v Slovenskih goricah, Slovenia, 2212
    • Pediatrija Sentilj
  • Slovenske Konjice, Slovenia, 3210
    • Zasebna pediatricna ambulanta Damir Dabranin
  • Tolmin, Slovenia, 5220
    • Zdravstveni Dom Tolmin
  • Trebnje, Slovenia, 8210
    • Zadravstveni dom Trebnje
  • Trebnje, Slovenia, 8210
    • Zdravstveni dom Trebnje
  • Trzic, Slovenia, 4290
    • Zasebna Otroska in Solska Ordinacija
  • Zagorje ob Savi, Slovenia
    • Zdravstveni dom Zagorje

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EpiCor and Vitamin C; EpiCor (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	Dietary supplement: EpiCor and Vitamin C; One daily dose
Active Comparator: Vitamin C; 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	Dietary supplement: Vitamin C; One daily dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the common cold and influenza	Daily Study Dairy	Duration of common cold and influenza during 12 weeks of product consumption
Severity of common cold and influenza	Canadian Acute Respiratory Illness and Flu Scale questionnaire	Severity of common cold and influenza symptoms during the 12 weeks of product consumption
Use of prescription drugs	Daily Study Dairy	Number of prescription drugs during the 12 weeks of product consumption
Change of salivary secretory immunoglobulin A (sIgA) levels	Salivary sIgA	Change of salivary sIgA levels after 6 and 12 weeks of product consumption
Safety of investigational product consumption	Adverse Events during the study period	Safety of investigational product consumption during the 12 weeks study period

Collaborators and Investigators

• Sponsor: Cargill
• Collaborators: Clinres Farmacija d.o.o.; PharmaLinea d.o.o.; Diagnostic Laboratory Medicare PLUS d.o.o.; Embria Health Sciences
• Investigators: Principal Investigator: Alojz Ihan, University of Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold; Signs and Symptoms, Respiratory; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid
• Other Study ID Numbers: EpiCor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No