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| Name | Class |
|---|---|
| Birmingham Children's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UNO EasiVits | Experimental | UNO EasiVits for 7 days |
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| DUO EasiVits | Experimental | DUO EasiVits for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNO EasiVits | Dietary Supplement | 7-day administration of UNO EasiVits |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita MacDonald, PhD | Birmingham Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2025 | May 8, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008661 | Metabolism, Inborn Errors |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| DUO EasiVits |
| Dietary Supplement |
7-day administration of DUO EasiVits |
|