Signs and Symptoms, RespiratoryNCT04093206
Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy Children
A study testing EpiCor and Vitamin C and Vitamin C in people with Signs and Symptoms, Respiratory, run by Cargill at 21 sites in Slovenia.
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… Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Respiratory
- What is being tested?
- EpiCor and Vitamin C and Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 21 sitesSlovenia
- Study dates
- 22 Dec 2017to 28 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Slovenia21 sites
Zdravstveni dom Domzale
Domžale, 1230
Zasebna pediatricna ordinacija Ivan Kauzlaric
Ilirska Bistrica, 6250
ZD Ivancna Gorica
Ivančna Gorica, 1295
Zdravstveni dom Kocevje
Kočevje, 1330
Ambulanta za otroke in solarje Pedenjped d.o.o.
Lenart V Slov Goricah, 2230
Zasebna otroska in solska ambulanta Mojca Ivankovic Kacjan
Lenart V Slov Goricah, 2230
Zasebna ambulanta Moj pediater Matjaz Homsak
Lenart V Slov. Goricah, 2230
Clinres Farmacija d.o.o.
Ljubljana, 1000
Zdravstveni dom Ljubljana
Ljubljana, 1000
Zasebna pediatricna ambulanta Vesna Lazar Daneu
Lucija, 6320
Pediatrinja Suzana Skorjanc Antolic Zdravstvena Dejavnost d.o.o.
Maribor, 2000
Zdravstveni dom Dr. Adolfa Droca Maribor
Maribor, 2000
Zdravstveni dom Dr. Adolfa Drolca Maribor
Maribor, 2000
Zdravstveni dom Nova Gorica
Sempeter pri Gorici, 5290
Pediatrija Sentilj
Šentilj v Slovenskih goricah, 2212
Zasebna pediatricna ambulanta Damir Dabranin
Slovenske Konjice, 3210
Zdravstveni dom Tolmin
Tolmin, 5220
Zadravstveni dom Trebnje
Trebnje, 8210
Zdravstveni dom Trebnje
Trebnje, 8210
Zasebna Otroska in Solska Ordinacija
Trzic, 4290
Zdravstveni dom Zagorje
Zagorje ob Savi
About this study
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
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.
Read the 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.
- Conditions
- Signs and Symptoms, Respiratory
- Being tested
- EpiCor and Vitamin C, Vitamin C
- Medical subject headings
- Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiCor and Vitamin CDietary supplement
One daily dose
Vitamin CDietary supplement
One daily dose
| Study group | Role | What they receive |
|---|---|---|
| EpiCor and Vitamin C | Experimental | 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 Receives: Dietary Supplement: EpiCor and Vitamin C |
| Vitamin C | Active comparator | 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 Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the common cold an influenza
Daily Study Dairy
Measured: Number of episodes of common cold and/or influenza during 12 weeks of product consumption
Secondary outcomes (5)
Duration of the common cold and influenza
Daily Study Dairy
Measured: 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
Measured: Severity of common cold and influenza symptoms during the 12 weeks of product consumption
Use of prescription drugs
Daily Study Dairy
Measured: Number of prescription drugs during the 12 weeks of product consumption
Change of salivary secretory immunoglobulin A (sIgA) levels
Salivary sIgA
Measured: Change of salivary sIgA levels after 6 and 12 weeks of product consumption
Safety of investigational product consumption
Adverse Events during the study period
Measured: Safety of investigational product consumption during the 12 weeks study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start22 Dec 2017
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and Symptoms, RespiratoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cargill
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinres Farmacija d.o.o., PharmaLinea d.o.o., Diagnostic Laboratory Medicare PLUS d.o.o., Embria Health Sciences
- Responsible party
- Sponsor
- Investigators
- Alojz Ihan, Principal investigator, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093206
- Sponsor's protocol ID
- EpiCor
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04093206
- Acronym / sponsor ID
- EpiCor
- Conditions
- Signs and Symptoms, Respiratory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- CargillIndustry (pharma, biotech, devices)
- Collaborators
- Clinres Farmacija d.o.o., PharmaLinea d.o.o., Diagnostic Laboratory Medicare PLUS d.o.o., Embria Health Sciences
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EpiCor and Vitamin C | Experimental | Dietary Supplement: EpiCor and Vitamin CEpiCor (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 |
| Vitamin C | Active comparator | Dietary Supplement: Vitamin CVitamin 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 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiCor and Vitamin COne daily dose | Dietary supplement | EpiCor and Vitamin C |
| Vitamin COne daily dose | Dietary supplement | Vitamin C |
Primary outcome
Incidence of the common cold an influenza
Time frame: Number of episodes of common cold and/or influenza during 12 weeks of product consumption
Daily Study Dairy
5 secondary outcomes
Duration of the common cold and influenza
Time frame: Duration of common cold and influenza during 12 weeks of product consumption
Severity of common cold and influenza
Time frame: Severity of common cold and influenza symptoms during the 12 weeks of product consumption
Use of prescription drugs
Time frame: Number of prescription drugs during the 12 weeks of product consumption
Change of salivary secretory immunoglobulin A (sIgA) levels
Time frame: Change of salivary sIgA levels after 6 and 12 weeks of product consumption
Safety of investigational product consumption
Time frame: Safety of investigational product consumption during the 12 weeks study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Related trials for Signs and Symptoms, Respiratory
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alojz Ihan principal investigator
University of Ljubljana
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiCor and Vitamin C and Vitamin C in people with Signs and Symptoms, Respiratory, run by Cargill at 21 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the common cold an influenza (time frame: Number of episodes of common cold and/or influenza during 12 weeks of product consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.