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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Kiddi® Pharmaton Fizz, effervescent tablets

with reduced amount of minerals

Group Type EXPERIMENTAL

Kiddi® Pharmaton Fizz, effervescent tablets

Intervention Type DRUG

Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula

Group Type ACTIVE_COMPARATOR

Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula

Intervention Type DRUG

Comparator product

in the form of a product that is a market leader

Group Type ACTIVE_COMPARATOR

Comparator product

Intervention Type DRUG

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

Interventions

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Kiddi® Pharmaton Fizz, effervescent tablets

Intervention Type DRUG

Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula

Intervention Type DRUG

Comparator product

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

Intervention Type DRUG

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)

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes