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

Seizure Disorders Clinical Trial

— FruitiVits  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229318
• Other study ID #: NA-FRV-012014-01
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2024
• Source: Vitaflo International, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizure Disorders
• Seizures

Intervention

Dietary Supplement:
• FruitiVits
Daily administration of FruitiVits dietary supplement

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia, Division of Neurology	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vitaflo International, Ltd	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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