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

Vitaflo International, Ltd11 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Seizure Disorders

Interventions

FruitiVitsDIETARY_SUPPLEMENT

Daily administration of FruitiVits dietary supplement

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 Years

Medical Language ↔ Plain English

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

Locations (1)

The Children's Hospital of Philadelphia, Division of Neurology

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Acceptability of FruitiVits

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).

Time frame: Day 8 of trial

Secondary Outcomes

Ease of Preparation of FruitiVits

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

Time frame: Day 8 of trial

Data from ClinicalTrials.gov

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