Inborn Errors of MetabolismEVATSNCT07619170
EasiVits Acceptability & Tolerance Study
A study testing UNO EasiVits and DUO EasiVits in people with Inborn Errors of Metabolism, run by NeoteriQ Ltd. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Inborn Errors of Metabolism
- What is being tested?
- UNO EasiVits and DUO EasiVits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Mar 2026to 23 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female IEM patients ages 1-16 years.
- Patients diagnosed with an IEM.
- Taking vitamin and mineral supplements for IEM and willing to take the new supplements for 7 days.
- Absence of comorbidities.
- Adherence with dietary management and vitamin and mineral supplements.
- Able to understand and comply with the requirements of the investigation and sign the Informed Consent Form/Assent form.
Who cannot join
- Age <1 years old.
- Patients with comorbidities.
- Any moderate to severe acute illness which in the opinion of the Investigator would interfere with the study procedures or study outcome.
- History of poor co-operation, non-adherence with dietary management, or poor adherence to investigation procedures.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- UNO EasiVits, DUO EasiVits
- Medical subject headings
- Metabolism, Inborn Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNO EasiVitsDietary supplement
7-day administration of UNO EasiVits
DUO EasiVitsDietary supplement
7-day administration of DUO EasiVits
| Study group | Role | What they receive |
|---|---|---|
| UNO EasiVits | Experimental | UNO EasiVits for 7 days Receives: Dietary Supplement: UNO EasiVits |
| DUO EasiVits | Experimental | DUO EasiVits for 7 days Receives: Dietary Supplement: DUO EasiVits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Product Acceptability
Acceptability measured using a non-validated questionnaire asking participants to rate their usual product (baseline) and the study product (end of study) in terms of appearance, smell, taste, texture, ease of mixing, ease of taking and aftertaste, using a 5-point Likert scale from Great to Terrible.
Measured: 7 days
Gastrointestinal Tolerance of Study Product
Gastrointestinal symptoms measured using a daily diary to record any episode of diarrhoea, constipation, bloating, nausea, vomiting, burping/regurgitation, flatulence or abdominal pain with a rating of none, mild, moderate or severe.
Measured: 7 days
Study Product Adherence
Adherence measured using a daily diary to record the amount of study product taken, how and when it was taken. This is then compared to the prescribed amount.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start7 Mar 2026
- Primary completion23 Sep 2026 (estimated)
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inborn Errors of MetabolismStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoteriQ Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Birmingham Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Anita MacDonald, PhD, Principal investigator, Birmingham Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619170
- Sponsor's protocol ID
- NeoteriQ
- Acronym
- EVATS
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EasiVits Acceptability & Tolerance Study
- ClinicalTrials.gov ID
- NCT07619170
- Acronym / sponsor ID
- EVATS / NeoteriQ
- Conditions
- Inborn Errors of Metabolism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NeoteriQ Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Birmingham Children's Hospital
- Study start
- 7 Mar 2026 (actual)
- Primary completion
- 23 Sep 2026 (estimated)
- Study completion
- 23 Sep 2026 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UNO EasiVits | Experimental | Dietary Supplement: UNO EasiVitsUNO EasiVits for 7 days |
| DUO EasiVits | Experimental | Dietary Supplement: DUO EasiVitsDUO EasiVits for 7 days |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female IEM patients ages 1-16 years.
- Patients diagnosed with an IEM.
- Taking vitamin and mineral supplements for IEM and willing to take the new supplements for 7 days.
- Absence of comorbidities.
- Adherence with dietary management and vitamin and mineral supplements.
Key exclusion criteria (5 listed)
- Age <1 years old.
- Patients with comorbidities.
- Any moderate to severe acute illness which in the opinion of the Investigator would interfere with the study procedures or study outcome.
- History of poor co-operation, non-adherence with dietary management, or poor adherence to investigation procedures.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
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 |
|---|---|---|
| UNO EasiVits7-day administration of UNO EasiVits | Dietary supplement | UNO EasiVits |
| DUO EasiVits7-day administration of DUO EasiVits | Dietary supplement | DUO EasiVits |
Primary outcome
Study Product Acceptability
Time frame: 7 days
Acceptability measured using a non-validated questionnaire asking participants to rate their usual product (baseline) and the study product (end of study) in terms of appearance, smell, taste, texture, ease of mixing, ease of taking and aftertaste, using a 5-point Likert scale from Great to Terrible.
Gastrointestinal Tolerance of Study Product
Time frame: 7 days
Gastrointestinal symptoms measured using a daily diary to record any episode of diarrhoea, constipation, bloating, nausea, vomiting, burping/regurgitation, flatulence or abdominal pain with a rating of none, mild, moderate or severe.
Study Product Adherence
Time frame: 7 days
Adherence measured using a daily diary to record the amount of study product taken, how and when it was taken. This is then compared to the prescribed amount.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
Anita MacDonald, PhD principal investigator
Birmingham Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNO EasiVits and DUO EasiVits in people with Inborn Errors of Metabolism, run by NeoteriQ Ltd. at 1 site in United Kingdom.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Study Product Acceptability (time frame: 7 days). The study lists 3 primary outcomes in all. 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 1 Jun 2026.