CompletedNCT02184325Updated Jul 14, 2014

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

A Phase 2 interventional study of Kiddi® Pharmaton Fizz, effervescent tablets and Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 6 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-14.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 96
Allocation: Randomized
Ages: 6 Years to 14 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 14 Years
Sexes eligible: All
Accepts 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

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)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double
Enrollment: 96 participants (actual)

Study arms

Experimental
Kiddi® Pharmaton Fizz, effervescent tablets
with reduced amount of minerals
Drug: Kiddi® Pharmaton Fizz, effervescent tablets
Active comparator
Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
Drug: Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
Active comparator
Comparator product
in the form of a product that is a market leader
Drug: 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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02184325
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Jul 9, 2014
Start date: Nov 1999
Primary completion: Feb 2000
Last update: Jul 14, 2014

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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