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Completed

NCT Number: NCT02184325

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

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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Key information

Conditions

Healthy

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Kiddi® Pharmaton Fizz, effervescent tablets

Drug

Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula

Drug

Comparator product

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

Primary outcomes

  1. Incidence of total drug-related adverse events

    Time frame: up to 19 days

Secondary outcomes

  1. Incidence of all individual drug-related adverse events

    Time frame: up to 19 days

  2. Assessment of overall tolerability and acceptance on a 4-point verbal rating scale

    Time frame: up to day 19

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2000
First posted
Jul 9, 2014
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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