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

• Sponsor: Cargill (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04093206
• Collaborator: Clinres Farmacija d.o.o. (Industry), PharmaLinea d.o.o. (Other), Diagnostic Laboratory Medicare PLUS d.o.o. (Other), Embria Health Sciences (Other)
• Enrollment: 221
• Locations: 21
• Arms: 2
• Actual Duration (Months): 15.1
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Signs and Symptoms, Respiratory	Dietary Supplement: EpiCor and Vitamin C; Dietary Supplement: Vitamin C	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 221 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Dec 22, 2017
• Actual Primary Completion Date: Mar 28, 2019
• Actual Study Completion Date: Mar 28, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Duration of the common cold and influenza [Duration of common cold and influenza during 12 weeks of product consumption]

   Daily Study Dairy

2. 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

3. Use of prescription drugs [Number of prescription drugs during the 12 weeks of product consumption]

   Daily Study Dairy

4. Change of salivary secretory immunoglobulin A (sIgA) levels [Change of salivary sIgA levels after 6 and 12 weeks of product consumption]

   Salivary sIgA

5. Safety of investigational product consumption [Safety of investigational product consumption during the 12 weeks study period]

   Adverse Events during the study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zdravstveni dom Domzale	Domžale		Slovenia	1230
2	Zasebna pediatricna ordinacija Ivan Kauzlaric	Ilirska Bistrica		Slovenia	6250
3	ZD Ivancna Gorica	Ivančna Gorica		Slovenia	1295
4	Zdravstveni dom Kocevje	Kocevje		Slovenia	1330
5	Ambulanta za otroke in solarje Pedenjped d.o.o.	Lenart v Slov Goricah		Slovenia	2230
6	Zasebna otroska in solska ambulanta Mojca Ivankovic Kacjan	Lenart v Slov Goricah		Slovenia	2230
7	Zasebna ambulanta Moj pediater Matjaz Homsak	Lenart V Slov. Goricah		Slovenia	2230
8	Clinres Farmacija d.o.o.	Ljubljana		Slovenia	1000
9	Zdravstveni dom Ljubljana	Ljubljana		Slovenia	1000
10	Zasebna pediatricna ambulanta Vesna Lazar Daneu	Lucija		Slovenia	6320
11	Pediatrinja Suzana Skorjanc Antolic Zdravstvena Dejavnost d.o.o.	Maribor		Slovenia	2000
12	Zdravstveni dom Dr. Adolfa Droca Maribor	Maribor		Slovenia	2000
13	Zdravstveni dom Dr. Adolfa Drolca Maribor	Maribor		Slovenia	2000
14	Zdravstveni dom Nova Gorica	Sempeter pri Gorici		Slovenia	5290
15	Pediatrija Sentilj	Sentilj v Slovenskih goricah		Slovenia	2212
16	Zasebna pediatricna ambulanta Damir Dabranin	Slovenske Konjice		Slovenia	3210
17	Zdravstveni dom Tolmin	Tolmin		Slovenia	5220
18	Zadravstveni dom Trebnje	Trebnje		Slovenia	8210
19	Zdravstveni dom Trebnje	Trebnje		Slovenia	8210
20	Zasebna Otroska in Solska Ordinacija	Trzic		Slovenia	4290
21	Zdravstveni dom Zagorje	Zagorje ob Savi		Slovenia

Sponsors and Collaborators

• Cargill
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cargill
• ClinicalTrials.gov Identifier: NCT04093206
• Other Study ID Numbers: EpiCor
• First Posted: Sep 17, 2019
• Last Update Posted: Sep 17, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Common Cold; Signs and Symptoms, Respiratory; Vitamins; Ascorbic Acid

Study Results

No Results Posted as of Sep 17, 2019