Seizure Disorders
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFruitiVits
Daily administration of FruitiVits dietary supplement
Sponsors
Children's Hospital of Philadelphia
Vitaflo International, Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of FruitiVits | 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
| Measure | Time frame | Description |
|---|---|---|
| Ease of Preparation of FruitiVits | 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 |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| FruitiVits Daily administration of FruitiVits dietary supplement | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | FruitiVits |
|---|---|
| Age, Categorical <=18 years | 11 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 6.7 years |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Acceptability of FruitiVits
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
Population: Children aged 4 to 8 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FruitiVits | Acceptability of FruitiVits | Smell score 1-3 | 10 participants |
| FruitiVits | Acceptability of FruitiVits | Taste score 1-3 | 6 participants |
| FruitiVits | Acceptability of FruitiVits | Texture score 1-3 | 6 participants |
| FruitiVits | Acceptability of FruitiVits | Appearance score 1-3 | 8 participants |
Secondary
Ease of Preparation of FruitiVits
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
Population: Children aged 4 to 8 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FruitiVits | Ease of Preparation of FruitiVits | 11 participants |