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Trial record 50 of 532 for:    Taste Disorders

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

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ClinicalTrials.gov Identifier: NCT02229318
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : October 7, 2016
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Vitaflo International, Ltd

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

Condition or disease Intervention/treatment Phase
Seizure Disorders Dietary Supplement: FruitiVits Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FruitiVits
Daily administration of FruitiVits dietary supplement
Dietary Supplement: FruitiVits
Daily administration of FruitiVits dietary supplement




Primary Outcome Measures :
  1. Acceptability of FruitiVits [ Time Frame: 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 :
  1. Ease of Preparation of FruitiVits [ Time Frame: 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




Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229318


Locations
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United States, Pennsylvania
The Children's Hospital of Philadelphia, Division of Neurology
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Vitaflo International, Ltd
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Christina Bergqvist, M.D Children's Hospital of Philadelphia

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Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT02229318     History of Changes
Other Study ID Numbers: NA-FRV-012014-01
First Posted: September 1, 2014    Key Record Dates
Results First Posted: October 7, 2016
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Seizures
Epilepsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases