Trial Outcomes & Findings for A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet. (NCT NCT02229318)

NCT ID: NCT02229318

Last Updated: 2024-03-13

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Day 8 of trial
• Results posted on: 2024-03-13

Participant Flow

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.

12 families invited to participate, one subject failed to attend the recruitment family day and did not enroll in the study.

Participant milestones

Measure	FruitiVits Daily administration of FruitiVits dietary supplement
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	FruitiVits n=11 Participants Daily administration of FruitiVits dietary supplement
Age, Categorical <=18 years	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	6.7 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8 of trial

Population: Children aged 4 to 8 years.

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).

Outcome measures

Measure	FruitiVits n=11 Participants Daily administration of FruitiVits dietary supplement
Acceptability of FruitiVits Taste score 1-3	6 participants
Acceptability of FruitiVits Appearance score 1-3	8 participants
Acceptability of FruitiVits Smell score 1-3	10 participants
Acceptability of FruitiVits Texture score 1-3	6 participants

SECONDARY outcome

Timeframe: Day 8 of trial

Population: Children aged 4 to 8 years.

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

Outcome measures

Measure	FruitiVits n=11 Participants Daily administration of FruitiVits dietary supplement
Ease of Preparation of FruitiVits	11 participants

Adverse Events

FruitiVits

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Christina Bergqvist, M.D., Study Principal Investigator

The Children's Hospital of Philadelphia

Phone: +1 215 590 1719

Email: Bergqvist@Email.CHoP.Edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place