Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children

Not Applicable

Completed

• Conditions: Signs and Symptoms, Respiratory
• Interventions: Dietary Supplement: Vitamin C; Dietary Supplement: EpiCor and Vitamin C

• Registration Number: NCT04093206
• Lead Sponsor: Cargill

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.

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 Timeline

• Study Start: 2017-12-22
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-28
• Status Verified: 2019-09
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Last Update Submitted: 2019-09-16
• Study First Posted: 2019-09-17
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin C	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
EpiCor and Vitamin C	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

Primary Outcome Measures

Name	Time	Method
Incidence of the common cold an influenza	Number of episodes of common cold and/or influenza during 12 weeks of product consumption	Daily Study Dairy

Secondary Outcome Measures

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

Trial Locations

Locations (21)

Zdravstveni dom Domzale; 🇸🇮 Domžale, Slovenia

Zasebna pediatricna ordinacija Ivan Kauzlaric; 🇸🇮 Ilirska Bistrica, Slovenia

ZD Ivancna Gorica; 🇸🇮 Ivančna Gorica, Slovenia

Zdravstveni dom Kocevje; 🇸🇮 Kocevje, Slovenia

Ambulanta za otroke in solarje Pedenjped d.o.o.; 🇸🇮 Lenart v Slov Goricah, Slovenia

Pediatrinja Suzana Skorjanc Antolic Zdravstvena Dejavnost d.o.o.; 🇸🇮 Maribor, Slovenia

Pediatrija Sentilj; 🇸🇮 Sentilj v Slovenskih goricah, Slovenia

Zasebna pediatricna ambulanta Damir Dabranin; 🇸🇮 Slovenske Konjice, Slovenia

Zadravstveni dom Trebnje; 🇸🇮 Trebnje, Slovenia

Zdravstveni dom Trebnje; 🇸🇮 Trebnje, Slovenia

Zdravstveni dom Tolmin; 🇸🇮 Tolmin, Slovenia

Zasebna Otroska in Solska Ordinacija; 🇸🇮 Trzic, Slovenia

Zdravstveni dom Zagorje; 🇸🇮 Zagorje ob Savi, Slovenia

Zasebna ambulanta Moj pediater Matjaz Homsak; 🇸🇮 Lenart V Slov. Goricah, Slovenia

Zdravstveni dom Dr. Adolfa Droca Maribor; 🇸🇮 Maribor, Slovenia

Zdravstveni dom Nova Gorica; 🇸🇮 Sempeter pri Gorici, Slovenia

Clinres Farmacija d.o.o.; 🇸🇮 Ljubljana, Slovenia

Zdravstveni dom Ljubljana; 🇸🇮 Ljubljana, Slovenia

Zdravstveni dom Dr. Adolfa Drolca Maribor; 🇸🇮 Maribor, Slovenia

Zasebna otroska in solska ambulanta Mojca Ivankovic Kacjan; 🇸🇮 Lenart v Slov Goricah, Slovenia

Zasebna pediatricna ambulanta Vesna Lazar Daneu; 🇸🇮 Lucija, Slovenia