Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets in Children

Study Overview
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Brief Summary
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Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product.

Official Title
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Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets, Comparing the Marketed Formula With an Improved One With a Reduced Mineral Amount, and a Comparator Product: a Double-blind, Controlled, Randomised, Three Arm Cross-over Study in Children

Conditions
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Healthy

Intervention / Treatment
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* Drug: Kiddi® Pharmaton Fizz, effervescent tablets
* Drug: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
* Drug: Comparator product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children of both sexes aged between 6 and 14 years, inclusive Children, healthy or during convalescence, for which prevention or treatment of marginal vitamin deficits is indicated Willingness of the children and parents to give their written informed consent, according to Good Clinical Practice and local regulations Pregnant children will not be excluded Exclusion Criteria: Has taken medications containing vitamins A or D, retinoids, or iron during the 4 weeks preceding the study enrolment Pre-treatment (less than 2 weeks prior the inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology, and may interfere with the evaluation of the safety of the test drug Participation in other clinical trials within the last 4 weeks and concurrent participation in another clinical trial Relevant allergy or kown hypersensitivity to one of the ingredients of the investigational drug Has any serious disorder that may interfere with the participation to the trial Malabsorption syndrome, liver and/or renal diseases or juvenile diabetes Increased calcium blood concentration, or an increased calcium-excretion Evident states of protein deficiency Presence of lysinemia (defect of the enzyme lysine ketoglutarate reductase)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kiddi® Pharmaton Fizz, effervescent tablets<br>with reduced amount of minerals | Drug: Kiddi® Pharmaton Fizz, effervescent tablets<br> <br> |
| Active Comparator: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula<br> | Drug: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula<br> <br> |
| Active Comparator: Comparator product<br>in the form of a product that is a market leader | Drug: Comparator product<br>* active substances: Vitamin A, Vitamin B1, Vitamin B2, Vitamin B5, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Manganese, Copper, Calcium, Magnesium, Phosphorous, Iron, Zinc, Sodium, Molybden<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of total drug-related adverse events |  | up to 19 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all individual drug-related adverse events |  | up to 19 days | 
| Assessment of overall tolerability and acceptance on a 4-point verbal rating scale |  | up to day 19 |