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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

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)