EasiVits Acceptability & Tolerance Study

Summary

In order to achieve metabolic stability, dietary treatment of inborn errors of metabolism (IEM) may require restriction of protein (e.g. phenylketonuria, tyrosinaemia, homocystinuria, organic acidaemias, maple syrup urine disease (MSUD), urea cycle disorders), fat (e.g. fatty acid oxidation disorders) or carbohydrate (e.g. glycogen storage disease). Manipulation of dietary intake potentially reduces micronutrient status, and provision of a comprehensive vitamin and mineral supplement may become an essential adjunct to dietary treatment.

Paediatric Seravit and Frutivits are vitamin and mineral supplements that are currently available on prescription. Paediatric Seravit is designed for children between 1-3 years of age but has high amounts of added carbohydrate, restricting its use for patients with IEM with restricted carbohydrate intake. Fruitivits is designed for children over the age of 3 years and is orange flavoured, restricting patient's choice, potentially leading to poor adherence and taste fatigue.

Previous studies show that despite improvements in some nutritional markers using the currently available vitamin and mineral supplements, overall use of the vitamin and mineral supplements was less than prescribed and alternatives are needed to guarantee delivery of micronutrients in children at risk of deficiencies as a result of an essential manipulation of diet in inborn disorders of metabolism. Whilst condition specific formula for IEM often contains added micronutrients, there are global concerns about over- and under-supplementation and the impact on palatability. Consequently, some health professionals advocate the availability of unfortified products to enable individualised tailoring of micronutrient intake using a separate vitamin and mineral supplement. Furthermore, with the advent of pharmacological treatments for some IEM, there is evidence that cessation of specialist formula without significant changes to dietary food intake, commonly leads to deficiencies in several micronutrients.

EasiVits are new vitamin and mineral supplements which contain minimal carbohydrate and are unflavoured. This allows them to be used in carbohydrate restricted IEMs, and patients can also add their preferred flavours via permitted fruit cordials or drinks in order to potentially improve adherence and prevent taste fatigue.

Conditions

• Inborn Errors of Metabolism

Interventions

DIETARY_SUPPLEMENT

UNO EasiVits

7-day administration of UNO EasiVits

DIETARY_SUPPLEMENT

DUO EasiVits

7-day administration of DUO EasiVits

Sponsors & Collaborators

• Birmingham Children's Hospital

  collaborator OTHER

• NeoteriQ Ltd.

  lead INDUSTRY

Principal Investigators

• Anita MacDonald, PhD · Birmingham Children's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-07

Primary Completion

2026-09-23

Completion

2026-09-23

Countries

• United Kingdom

Study Locations