International, multicentre, prospective, randomized, double-blind, placebo-controlled study with a food supplement Imunoglukan P4H® chewable tablets to evaluate preventive effect on reduction of respiratory tract infections (RTIs) in children with a history of recurrent respiratory tract infections (RRTIs) in the previous infectious season prior enrolment. Participants or their guardians will record the incidence and duration of RTIs in the Patient diary for 3 months.
Study population: Children aged 3-18 years with a history of RRTIs: * Age 3 to 5 years (\< 6 years): 6 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023 * Age 6 to 18 years (≥ 6 years): 3 or more upper or lower respiratory tract infections from October 2022 until the end of March 2023 Study design: International (Slovak republic, Czech republic, Serbia), multicentre (36), prospective, randomized, double-blind, placebo-controlled study Primary endpoint: To evaluate the effect of Imunoglukan P4H® chewable tablets (IMG®+ zinc+ vitamin D3) compared to the placebo group (zinc + vitamin D3) on: • reduction in the number of RTIs episodes (total number) Secondary endpoints: To evaluate the effect of Imunoglukan P4H® chewable tablets (IMG®+ zinc+ vitamin D3) compared to the placebo group (zinc + vitamin D3) on: * reduction in the number of episodes of RTI subtypes * reduction in the duration of RTI episodes (total duration, RTI subtypes) * reduction of the need for antibiotic (ATB) therapy * reduction of the number of missed days at school/nursery due to RTI * reduction of the number of missed working days due to RTIs * reduction of the number of emergency department visits due to RTI * reduction of the number of physician visits due to RTI * tolerability and safety Randomization: * Active group: Imunoglukan P4H® chewable tablets (IMG® 50 mg + Zinc 5 mg + Vitamin D3 10 μg in 1 tablet): * Placebo group: Placebo chewable tablets (Zinc 5 mg + Vitamin D 10 μg in 1 tablet) Dosage: * up to 25 kg of body weight 1 tablet once a day for 3 months * over 25 kg 2 tablets once a day for 3 months Diagnostic procedures: • Patient diary (Incidence and duration of RTIs)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
217
IMG® 50 mg + Zinc 5 mg + Vitamin D 10 μg in 1 tablet
Zinc 5 mg + Vitamin D 10 μg in 1 tablet
IMUNOGLUKAN CZ, s.r.o.
Prague, Czechia
Medis Pharma d.o.o. Beograd
Belgrade, Serbia
Imunoglukan, s.r.o.
Bratislava, Slovakia
change in the number of RTIs episodes (total number)
number of episodes of respiratory infections will be compared between the two study goups
Time frame: change in the number of RTIs episodes (total number) during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
change in the number of episodes of RTI subtypes
Time frame: change in the number of RTIs episodes (subtypes) during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
change in the duration of RTI episodes (total duration, RTI subtypes)
Time frame: change in the duration of RTIs episodes (total duration, subtypes) during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
change in the number of antibiotic therapy courses
Time frame: change in the number of antibiotic (ATB) therapy courses during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
change of the number of missed days at school/nursery due to RTI
Time frame: change of the number of missed days at school/nursery due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
change of the number of missed working days due to RTIs
Time frame: change of the number of missed working days due to RTIs during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
changeof the number of emergency department visits due to RTI
Time frame: changeof the number of emergency department visits due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
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change of the number of physician visits due to RTI
Time frame: change of the number of physician visits due to RTI during 3 month supplementation (from enrollment to the end of the treatment at 3 months)
tolerability and safety
monitoring the incidence of potential adverse events, incidence will be compared to placebo group
Time frame: during 3 month supplementation (from enrollment to the end of the treatment at 3 months)