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Trial record 40 of 531 for:    Taste Disorders AND taste

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Seizure Disorders
Intervention Dietary Supplement: FruitiVits
Enrollment 11
Recruitment Details Children between the ages of 4 and 8 years, attending the Ketogenic Diet Center at The Children’s Hospital of Philadelphia were invited by email to attend a study family day held on a Saturday afternoon in September 2014. The first 12 families to respond were contacted via telephone and invited to enroll in the study.
Pre-assignment Details 12 families invited to participate, one subject failed to attend the recruitment family day and did not enroll in the study.
Arm/Group Title FruitiVits
Hide Arm/Group Description Daily administration of FruitiVits dietary supplement
Period Title: Overall Study
Started 11 [1]
Completed 11 [2]
Not Completed 0
[1]
September 6th 2014 11 enrolled
[2]
September 15th 2014 11 completed
Arm/Group Title FruitiVits
Hide Arm/Group Description Daily administration of FruitiVits dietary supplement
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
11
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
6.7
(4.3 to 8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
8
  72.7%
Male
3
  27.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Acceptability of FruitiVits
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Children aged 4 to 8 years.
Arm/Group Title FruitiVits
Hide Arm/Group Description:
Daily administration of FruitiVits dietary supplement
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
Appearance score 1-3 8
Smell score 1-3 10
Taste score 1-3 6
Texture score 1-3 6
2.Secondary Outcome
Title Ease of Preparation of FruitiVits
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Children aged 4 to 8 years.
Arm/Group Title FruitiVits
Hide Arm/Group Description:
Administration of FruitiVits dietary supplement
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
11
Time Frame 7 days per patient
Adverse Event Reporting Description

A symptom diary was completed for each patient specifically asking about the following:

Nausea and/or vomiting Diarrhea and/or constipation Gas, flatulence and/or regurgitation Abdominal bloating and/or distention Abdominal discomfort and/or pain

 
Arm/Group Title FruitiVits
Hide Arm/Group Description Daily administration of FruitiVits dietary supplement
All-Cause Mortality
FruitiVits
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FruitiVits
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FruitiVits
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Christina Bergqvist, M.D., Study Principal Investigator
Organization: The Children's Hospital of Philadelphia
Phone: +1 215 590 1719
Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT02229318     History of Changes
Other Study ID Numbers: NA-FRV-012014-01
First Submitted: August 26, 2014
First Posted: September 1, 2014
Results First Submitted: September 7, 2015
Results First Posted: October 7, 2016
Last Update Posted: May 1, 2019