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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02184325

Enrollment

Registered

2014-07-09

Start date

1999-11-30

Completion date

Unknown

Last updated

2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGKiddi® Pharmaton Fizz, effervescent tablets

DRUGKiddi® Pharmaton Fizz, effervescent tablets: marketed formula

DRUGComparator 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Incidence of total drug-related adverse events	up to 19 days

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026