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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06298292
Other study ID # ZerominisCT01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date June 30, 2026

Study information

Verified date March 2024
Source metaX Institut fuer Diatetik GmbH
Contact Bernhard Hoffmann, PhD
Phone +49 6031 166 72 71
Email behoffmann@metax.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years.


Description:

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Study Design


Intervention

Dietary Supplement:
Zero minis (range of protein substitutes in tablet form)
Intervention: range of protein substitute tablets. Subjects who currently take a protein substitute for the dietary management of either tyrosinaemias or alkaptonuria, homocystinuria, or MSUD will be recruited. Subjects will take the study product for 7 days. Daily questionnaires will be completed (ease of preparation,administration; any problems or gastrointestinal effects). Subjects will replace some or their entire usual protein substitute with the new product suitable for their diagnosed rare metabolic disease. The amount of tablets prescribed will be calculated to provide the same amount of protein as their usual protein substitute. Additional questions at the beginning and end of the study will record information on organoleptic properties, presentation and packaging of the product. Routine weekly blood samples will be collected and analysed for amino acids typically for the metabolic control of the individual specified metabolic disorders as is usual clinical practice.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
metaX Institut fuer Diatetik GmbH Birmingham Women's and Children's NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary Daily compliance Compliance, with currently prescribed protein substitute will be assessed at the beginning of the 7-days trial. Usage and compliance with the study product will subsequently assessed daily from days 1-7 using standardised questionnaires, where patients document the the amount of consumed study product vs the prescribed doses. 7 days
Secondary Treatment-Emergent tolerability Gastro-intestinal side effects (including diarrhoea, constipation, bloating or abdominal distension, nausea, vomiting, burping, flatulence or regurgitation and abdominal discomfort or pain) will be assessed daily via questionnaire using the scale (none today, mild, moderate or severe / really troublesome). 7 days
Secondary Patient Acceptability Acceptability (ease of use and palatability) will be assessed via questionnaire daily during the study period and at the end of the study via questionnaire . 7 days
Secondary Metabolic control Weekly routine blood samples will be collected and analysed for specific amino acids typically for the metabolic control of the individual specified metabolic disorders as is usual clinical practice. 7 days
Secondary Incidence of study product emergent events. All adverse events will be recorded throughout the study (as and when they occur). There is no specific time frame as the frequency of adverse events can not be predicted. But as the study product is already commercially available occurence of any adverse event is unlikely. 7 days
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Active, not recruiting NCT01916382 - Suitability of Nitisinone in Alkaptonuria 2 Phase 3