An interventional study of EpiCor and Placebo in Signs and Symptoms, Respiratory, sponsored by Cargill. Completed at 1 site in Canada. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Cargill · Not applicable, Interventional, and Treatment
This is a double-blind, randomized, placebo-controlled study. The purpose of the clinical study is to determine the difference between 84 days of once daily oral EpiCor supplementation compared to placebo on the incidence of cold or flu symptoms among children aged 4-12 years who are attending school or daycare.
This double-blind, randomized, placebo-controlled study aims to determine the difference between 84 days of once daily oral EpiCor supplementation compared to placebo on the incidence of cold or flu symptoms among children aged 4-12 years who are attending school or daycare. Healthy children, with parental consent, are included in the study. The study includes one screening visit (day -45 to -15), a run-in period (day -14 to -1), and 3 clinical visits: day 0 (baseline), day 42, and day 84 (end of study). During the screening visit, the investigator reviews medical history, concomitant therapies, current health status, assesses inclusion and exclusion criteria, vital signs, weight and height measurements, assesses pre-emergent adverse events, and dispenses saliva collection kit for salivary Immunoglobulin A (IgA) analysis as well as study dairy and Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire. Participants complete the CARIFS questionnaire and study dairy during the run-in period. On day 0, participants return to the clinic with their saliva collecting kit, completed study diaries, and CARIFS questionnaire for baseline assessments; during this visit, eligible participants are randomized and they are also instructed to initiate investigational product administration on the morning of day 1. At day 42, participants and their caregivers return to the clinic for assessments with unused investigation product, saliva collection kit, completed study diaries, CARIFS questionnaire, and a Questionnaire for measuring health-related Quality of Life in Children and Adolescents (KINDL); investigator reviews concomitant therapies and adverse events, dispenses new study diary, CARIFS questionnaire, saliva collection kit, investigational product, and measures vital signs, weight, and height. The same procedure is repeated during the last clinical visit at day 84 (end of study), except that no investigational product is provided. Daily throughout the study, participant caregivers complete the study diary to track missed school or daycare days, well days, use of prescription/non-prescription cold/flu medication, adverse events, and concomitant therapies, and cold or flu symptoms (via CARIFS questionnaire when cold or flu symptoms are present).
79 studies on the registry are indexed under Signs and Symptoms, Respiratory; 9 are open to participants now.
This study's enrollment of 256 is above the median of 95 across 54 interventional studies indexed under Signs and Symptoms, Respiratory.
Browse Signs and Symptoms, Respiratory studies →Cargill is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
500 mg EpiCor given as two gummy supplements. Participants will be instructed to take two gummies per day in the morning, with or without food, for 84 days, starting on Day 1.
Dietary Supplement: EpiCor
Two gummy supplements. Participants will be instructed to take two gummies per day in the morning, with or without food, for 84 days, starting on Day 1.
Dietary Supplement: Placebo
2 gummies daily
2 gummies daily
Incidence of cold or flu symptoms
To determine the difference between 84 days of once daily oral EpiCor supplementation compared to placebo on the incidence of cold or flu symptoms among children aged 4-12 years who are attending school or daycare.
Time frame: 84 days
Incidence on cold or flu symptoms from baseline to day 42
Determine the difference between EpiCor and placebo from baseline to day 42 on the incidence of cold or flu symptoms during an 84-day supplementation period
Time frame: 42 days
Severity of cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84, assessed of the individual items on CARIFS and by area under the curve (AUC) for the CARIFS daily symptom score. The CARIFS questionnaire includes 18 items answered on a 4-point scale (no problem = 0, minor problem = 1, moderate problem = 2, major problem = 3) across three domains (symptoms, function, and parental impact). The higher the score, the more sever the illness.
Time frame: At 42 and 84 days
Duration of cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time frame: At 42 and 84 days
Proportion of children with no cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time frame: At 42 and 84 days
Number of days prior to first cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time frame: At 42 and 84 days
Number of missed school or daycare days due to cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time frame: At 42 and 84 days
Number of well days, related to the absence of cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time frame: At 42 and 84 days
Use of prescription and non-prescription cold/flu medications to treat cold or flu symptoms
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time frame: At 42 and 84 days
Saliva secretory immunoglobulin A concentrations
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84
Time frame: At 42 and 84 days
Quality of life as assessed by the KINDL questionnaire
To determine the difference between EpiCor compared to placebo from baseline to day 42 and to day 84. The KINDL questionnaire will be used to assess quality of life. This questionnaire contains 46 questions (scored 1-5; 1 - never, 2 - seldom, 3 - sometimes, 4 - often, 5 - all the time) answered by the caregiver.
Time frame: At 42 and 84 days
Safety profile as assessed by Adverse Events (AEs)
To determine EpiCor safety profile in children aged 4-12 years as assessed by AEs for 42 and 84 days.
Time frame: At 42 and 84 days
Safety profile as assessed by vital sign blood pressure
To determine EpiCor safety profile in children aged 4-12 years as assessed by blood pressure for 42 and 84 days.
Time frame: At 42 and 84 days
Safety profile as assessed by vital sign heart rate
To determine EpiCor safety profile in children aged 4-12 years as assessed by heart rate for 42 and 84 days.
Time frame: At 42 and 84 days
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Signs and Symptoms, Respiratory→
Cargill