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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
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Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FruitiVits | Experimental | Daily administration of FruitiVits dietary supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FruitiVits | Dietary Supplement | Daily administration of FruitiVits dietary supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of FruitiVits | The study product was rated on a scale of 1-5:
| Day 8 of trial |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Preparation of FruitiVits | Ease of preparation of FruitiVits was rated on a scale of 1-5:
Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients | Day 8 of trial |
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Inclusion Criteria:
Exclusion Criteria:
1) Children aged less than 4 years or older than 9 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Christina Bergqvist, M.D | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia, Division of Neurology | Philadelphia | Pennsylvania | 19104 | United States |
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12 families invited to participate, one subject failed to attend the recruitment family day and did not enroll in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | FruitiVits | Daily administration of FruitiVits dietary supplement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FruitiVits | Daily administration of FruitiVits dietary supplement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of FruitiVits | The study product was rated on a scale of 1-5:
| Children aged 4 to 8 years. | Posted | Number | participants | Day 8 of trial |
|
|
7 days per patient
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FruitiVits | Daily administration of FruitiVits dietary supplement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Christina Bergqvist, M.D., Study Principal Investigator | The Children's Hospital of Philadelphia | +1 215 590 1719 | Bergqvist@Email.CHoP.Edu |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Ease of Preparation of FruitiVits | Ease of preparation of FruitiVits was rated on a scale of 1-5:
Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients | Children aged 4 to 8 years. | Posted | Number | participants | Day 8 of trial |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
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