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

• 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: Vitaflo International, Ltd
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		FruitiVits
Arm/Group Description		Daily administration of FruitiVits dietary supplement
Overall Number of Baseline Participants		11
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

Outcome Measures

1. Primary Outcome

Title	Acceptability of FruitiVits
Description	The study product was rated on a scale of 1-5: (liked very much); (liked moderately); (neither liked nor disliked); (disliked moderately); (disliked very much).
Time Frame	Day 8 of trial

Outcome Measure Data

Analysis Population Description

Children aged 4 to 8 years.

Arm/Group Title	FruitiVits
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
Description	Ease of preparation of FruitiVits was rated on a scale of 1-5: (very easy); (moderately easy); (neither easy nor difficult); (moderately difficult); (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

Outcome Measure Data

Analysis Population Description

Children aged 4 to 8 years.

Arm/Group Title	FruitiVits
Arm/Group Description:	Administration of FruitiVits dietary supplement
Overall Number of Participants Analyzed	11
Measure Type: Number; Unit of Measure: participants
	11

Adverse Events

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
Arm/Group Description	Daily administration of FruitiVits dietary supplement
All-Cause Mortality
	FruitiVits
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	FruitiVits
	Affected / at Risk (%)
Total	0/11 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	FruitiVits
	Affected / at Risk (%)
Total	0/11 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: Bergqvist@Email.CHoP.Edu

• 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