Status:
COMPLETED
Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets in Children
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
6-14 years
Phase:
PHASE2
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 (...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT02184325
Start Date
November 1 1999
Last Update
July 14 2014
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