NCT02229318

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Vitaflo International, Ltd · Industry
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Seizure Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	FruitiVits	Daily administration of FruitiVits dietary supplement

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-09-01
• Last updated: 2024-03-13
• Results posted: 2016-10-07

Locations

1 site across 1 country: United States