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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-10-31

Brief Summary

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

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Detailed Description

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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

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Seizure Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FruitiVits

Daily administration of FruitiVits dietary supplement

Group Type EXPERIMENTAL

FruitiVits

Intervention Type DIETARY_SUPPLEMENT

Daily administration of FruitiVits dietary supplement

Interventions

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FruitiVits

Daily administration of FruitiVits dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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