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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

Tracking Information
First Submitted Date  ICMJE August 26, 2014
First Posted Date  ICMJE September 1, 2014
Results First Submitted Date  ICMJE September 7, 2015
Results First Posted Date  ICMJE October 7, 2016
Last Update Posted Date May 1, 2019
Study Start Date  ICMJE September 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
To assess from subject questionnaires the acceptance of the study product (Fruitivits) in children aged 4-8 years following a Ketogenic diet. [ Time Frame: Day 8 of trial ]
Change History Complete list of historical versions of study NCT02229318 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
To qualitatively asses from subject questionnaires the taste, ease of use and tolerance of the study product.(FruitiVits). [ Time Frame: Day 8 of trial ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Seizure Disorders
Intervention  ICMJE Dietary Supplement: FruitiVits
Daily administration of FruitiVits dietary supplement
Study Arms  ICMJE Experimental: FruitiVits
Daily administration of FruitiVits dietary supplement
Intervention: Dietary Supplement: FruitiVits
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2016)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2014)
12
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229318
Other Study ID Numbers  ICMJE NA-FRV-012014-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Vitaflo International, Ltd
Study Sponsor  ICMJE Vitaflo International, Ltd
Collaborators  ICMJE Children's Hospital of Philadelphia
Investigators  ICMJE
Principal Investigator: Christina Bergqvist, M.D Children's Hospital of Philadelphia
PRS Account Vitaflo International, Ltd
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP