Skip to main content
OpenTrials
Completed

NCT Number: NCT02229318

A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.

Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Seizure Disorders Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia, Division of Neurology

Philadelphia, Pennsylvania, 19104, United States

About this study

The study will involve 12 subjects between 4 and 8 years of age, who routinely use comprehensive micronutrient supplementation as part of their dietary management.

Primary Hypothesis:

FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a Ketogenic diet.

Secondary Hypothesis:

FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic diet.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of condition requiring a Ketogenic diet
  • Currently on a Ketogenic diet
  • Aged 4 - 8 years
  • Routinely taking a complete micronutrient supplement
  • Oral feeding

Exclusion criteria

  • Children aged less than 4 years or older than 9 years of age

Treatment and study plan

FruitiVits

Dietary Supplement

Daily administration of FruitiVits dietary supplement

Primary outcomes

  1. Acceptability of FruitiVits

    Time frame: Day 8 of trial

    The study product was rated on a scale of 1-5:

    • (liked very much)
    • (liked moderately)
    • (neither liked nor disliked)
    • (disliked moderately)
    • (disliked very much).

Secondary outcomes

  1. Ease of Preparation of FruitiVits

    Time frame: Day 8 of trial

    Ease of preparation of FruitiVits was rated on a scale of 1-5:

    • (very easy)
    • (moderately easy)
    • (neither easy nor difficult)
    • (moderately difficult)
    • (very difficult).

    Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients

Sponsors and collaborators

Lead sponsor

Vitaflo International, Ltd

Industry

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.

Acronym: FruitiVits

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 1, 2014
Registry last updated
Mar 13, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.