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

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.

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

Study Overview

• Status: Completed
• Conditions: Seizure Disorders
• Intervention / Treatment: Dietary supplement: FruitiVits

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia, Division of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of condition requiring a Ketogenic diet
2. Currently on a Ketogenic diet
3. Aged 4 - 8 years
4. Routinely taking a complete micronutrient supplement
5. Oral feeding

Exclusion Criteria:

1) Children aged less than 4 years or older than 9 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FruitiVits; Daily administration of FruitiVits dietary supplement	Dietary supplement: FruitiVits; Daily administration of FruitiVits dietary supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of FruitiVits	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).	Day 8 of trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Preparation of FruitiVits	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	Day 8 of trial

Collaborators and Investigators

• Sponsor: Vitaflo International, Ltd
• Collaborators: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Christina Bergqvist, M.D, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 28, 2014
• First Posted (Estimated): September 1, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: NA-FRV-012014-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO