Seizure DisordersFruitiVitsNCT02229318
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
A study testing FruitiVits in people with Seizure Disorders, run by Vitaflo International, Ltd at 1 site in United States.
Trial summary
Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Seizure Disorders
- What is being tested?
- FruitiVits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of condition requiring a Ketogenic diet
- Currently on a Ketogenic diet
- Aged 4 - 8 years
- Routinely taking a complete micronutrient supplement
- Oral feeding
Who cannot join
- 1) Children aged less than 4 years or older than 9 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia, Division of Neurology
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.
Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.
Read the 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.
- Conditions
- Seizure Disorders
- Being tested
- FruitiVits
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruitiVitsDietary supplement
Daily administration of FruitiVits dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| FruitiVits | Experimental | Daily administration of FruitiVits dietary supplement Receives: Dietary Supplement: FruitiVits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of FruitiVits
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).
Measured: Day 8 of trial
Secondary outcomes (1)
Ease of Preparation of FruitiVits
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
Measured: Day 8 of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seizure DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaflo International, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Christina Bergqvist, M.D, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229318
- Sponsor's protocol ID
- NA-FRV-012014-01
- Acronym
- FruitiVits
- Status last verified
- Feb 2024
- First submitted
- 26 Aug 2014
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.
- ClinicalTrials.gov ID
- NCT02229318
- Acronym / sponsor ID
- FruitiVits / NA-FRV-012014-01
- Conditions
- Seizure Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vitaflo International, LtdIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Posted 7 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FruitiVits | Experimental | Dietary Supplement: FruitiVitsDaily administration of FruitiVits dietary supplement |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of condition requiring a Ketogenic diet
- Currently on a Ketogenic diet
- Aged 4 - 8 years
- Routinely taking a complete micronutrient supplement
- Oral feeding
Key exclusion criteria (1 listed)
- 1) Children aged less than 4 years or older than 9 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FruitiVitsDaily administration of FruitiVits dietary supplement | Dietary supplement | FruitiVits |
Primary outcome
Acceptability of FruitiVits
Time frame: 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).
1 secondary outcome
Ease of Preparation of FruitiVits
Time frame: Day 8 of trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Bergqvist, M.D principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FruitiVits in people with Seizure Disorders, run by Vitaflo International, Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of FruitiVits (time frame: Day 8 of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.