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

Not Applicable

Completed

• Conditions: Seizure Disorders
• Interventions: Dietary Supplement: FruitiVits

• Registration Number: NCT02229318
• Lead Sponsor: Vitaflo International, Ltd

Brief 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.

Study Timeline

• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-28
• Study Start: 2014-09
• Study First Posted: 2014-09-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-09-07
• Results First Submitted QC: 2016-08-15
• Results First Posted: 2016-10-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FruitiVits	FruitiVits	Daily administration of FruitiVits dietary supplement

Primary Outcome Measures

Name	Time	Method
Acceptability of FruitiVits	Day 8 of trial	The study product was rated on a scale of 1-5: 1. (liked very much); 2. (liked moderately); 3. (neither liked nor disliked); 4. (disliked moderately); 5. (disliked very much).

Secondary Outcome Measures

Name	Time	Method
Ease of Preparation of FruitiVits	Day 8 of trial	Ease of preparation of FruitiVits was rated on a scale of 1-5: 1. (very easy); 2. (moderately easy); 3. (neither easy nor difficult); 4. (moderately difficult); 5. (very difficult).; Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia, Division of Neurology; 🇺🇸 Philadelphia, Pennsylvania, United States