NCT02229318

Brief Summary

Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 7, 2016

Completed
Last Updated

March 13, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

August 26, 2014

Results QC Date

September 7, 2015

Last Update Submit

February 15, 2024

Conditions

Seizure Disorders

Outcome Measures

Primary Outcomes (1)

  • 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).

    Day 8 of trial

Secondary Outcomes (1)

  • Ease of Preparation of FruitiVits

    Day 8 of trial

Study Arms (1)

FruitiVits

EXPERIMENTAL

Daily administration of FruitiVits dietary supplement

Dietary Supplement: FruitiVits

Interventions

FruitiVitsDIETARY_SUPPLEMENT

Daily administration of FruitiVits dietary supplement

FruitiVits

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of condition requiring a Ketogenic diet
  • Currently on a Ketogenic diet
  • Aged 4 - 8 years
  • Routinely taking a complete micronutrient supplement
  • Oral feeding

You may not qualify if:

  • \) Children aged less than 4 years or older than 9 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia, Division of Neurology

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Dr Christina Bergqvist, M.D., Study Principal Investigator
Organization
The Children's Hospital of Philadelphia
Bergqvist@Email.CHoP.Edu
+1 215 590 1719

Study Officials

  • Christina Bergqvist, M.D

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

September 1, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 13, 2024

Results First Posted

October 7, 2016

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)