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

Vitaflo

Status: Completed

Conditions: Seizure Disorders

Treatments: Dietary Supplement: FruitiVits

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02229318

NA-FRV-012014-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

FruitiVits

Experimental group

Description:

Daily administration of FruitiVits dietary supplement

Treatment:

Dietary Supplement: FruitiVits