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

Signs and Symptoms, Respiratory Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093206
• Other study ID #: EpiCor
• Status: Completed
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: March 28, 2019

Study information

• Verified date: September 2019
• Source: Cargill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Signs and Symptoms
• Signs and Symptoms, Respiratory

Intervention

Dietary Supplement:
• EpiCor and Vitamin C
One daily dose
• Vitamin C
One daily dose

Locations

Country	Name	City	State
Slovenia	Zdravstveni dom Domzale	Domžale
Slovenia	Zasebna pediatricna ordinacija Ivan Kauzlaric	Ilirska Bistrica
Slovenia	ZD Ivancna Gorica	Ivancna Gorica
Slovenia	Zdravstveni dom Kocevje	Kocevje
Slovenia	Ambulanta za otroke in solarje Pedenjped d.o.o.	Lenart v Slov Goricah
Slovenia	Zasebna otroska in solska ambulanta Mojca Ivankovic Kacjan	Lenart v Slov Goricah
Slovenia	Zasebna ambulanta Moj pediater Matjaz Homsak	Lenart V Slov. Goricah
Slovenia	Clinres Farmacija d.o.o.	Ljubljana
Slovenia	Zdravstveni dom Ljubljana	Ljubljana
Slovenia	Zasebna pediatricna ambulanta Vesna Lazar Daneu	Lucija
Slovenia	Pediatrinja Suzana Skorjanc Antolic Zdravstvena Dejavnost d.o.o.	Maribor
Slovenia	Zdravstveni dom Dr. Adolfa Droca Maribor	Maribor
Slovenia	Zdravstveni dom Dr. Adolfa Drolca Maribor	Maribor
Slovenia	Zdravstveni dom Nova Gorica	Sempeter pri Gorici
Slovenia	Pediatrija Sentilj	Sentilj v Slovenskih goricah
Slovenia	Zasebna pediatricna ambulanta Damir Dabranin	Slovenske Konjice
Slovenia	Zdravstveni dom Tolmin	Tolmin
Slovenia	Zadravstveni dom Trebnje	Trebnje
Slovenia	Zdravstveni dom Trebnje	Trebnje
Slovenia	Zasebna Otroska in Solska Ordinacija	Trzic
Slovenia	Zdravstveni dom Zagorje	Zagorje ob Savi

Sponsors (5)

Lead Sponsor	Collaborator
Cargill	Clinres Farmacija d.o.o., Diagnostic Laboratory Medicare PLUS d.o.o., Embria Health Sciences, PharmaLinea d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of the common cold and influenza	Daily Study Dairy	Duration of common cold and influenza during 12 weeks of product consumption
Secondary	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
Secondary	Use of prescription drugs	Daily Study Dairy	Number of prescription drugs during the 12 weeks of product consumption
Secondary	Change of salivary secretory immunoglobulin A (sIgA) levels	Salivary sIgA	Change of salivary sIgA levels after 6 and 12 weeks of product consumption
Secondary	Safety of investigational product consumption	Adverse Events during the study period	Safety of investigational product consumption during the 12 weeks study period