Status:
COMPLETED
Evaluation of TYR Sphere in France
Lead Sponsor:
Vitaflo International, Ltd
Conditions:
Tyrosinemia
AKU
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
10 participants aged 3 years and over with tyrosinaemia or alkaptonuria will be prescribed Tyr sphere following an assessment of their individual needs by their dietitian. All participants will enter...
Detailed Description
10 participants with tyrosinaemia or alkaptonuria will be invited to participate in this study. Following consent they will be assessed by their dietitian and a recommended amount of Tyr sphere will b...
Eligibility Criteria
Inclusion
- Diagnosed with tyrosinaemia.
- Aged ≥ 3 years.
- In the opinion of the Investigator, can comply with the study protocol and take at least one sachet of the study product per day.
- Willingly given, written, informed consent from patient or parent/guardian.
- Willingly given, written assent (if appropriate).
Exclusion
- Individuals who are allergic to milk, fish and soya (these allergens are inherent in the study product ingredients).
- Use of additional macro/micronutrient supplements during the evaluation period, unless clinically indicated and prescribed by the Investigator (must be recorded in patient case report form CRF).
- Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study.
- N.B.: Women who become pregnant during the study will no longer be able to participate and will be withdrawn.
- Individuals who, in the opinion of the investigator, are unable to comply with the requirements of the protocol.
- Any co-morbidity, which, in the opinion of the Investigator, would preclude participation in the study.
- Patients who are currently participating in, plan to participate in, or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to screening visit.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04761588
Start Date
December 1 2021
End Date
October 31 2025
Last Update
November 28 2025
Active Locations (1)
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1
Hopital Necker-Enfants Malades
Paris, France