Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03777826
Status:
COMPLETED
Last Update Posted:
2021-12-09
First Post:
2018-11-19
Brief Title:
Effects of Synergy on Nutrient Intake and Acceptability in Phenylketonuria PKU
Sponsor:
Nutricia Research
Organization:
Nutricia Research
Study Overview
Official Title:
An Open-label Explorative Post Launch Multicenter Multi-country Intervention Study of PKU Synergy an Amino-acid Mixture to Evaluate Change in Nutrient Intake in PKU Subjects With an Increased Phe-toleranceIntake
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESSENTIAL
Brief Summary:
Phenylketonuria PKU is a rare inherited metabolic disorder where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme PAH which leaves them unable to convert Phenylalanine Phe into Tyrosine Tyr Patients with mild PKU or partly responsive to the drug synthetic tetrahydrobiopterin BH4 Kuvan can change to a more relaxed diet However due to difficulty to adapt their diet these patients are at risk of an imbalanced nutritional status and an insufficient intake of specific micronutrients essential amino acids and DHA Docosahexaenoic acid The study product is designed to improve the nutritional status of the patients
The study investigates if the nutritional status is indeed improved following 24 week use of the study product and also the study aims to evaluate product acceptability
The study investigates if the nutritional status is indeed improved following 24 week use of the study product and also the study aims to evaluate product acceptability
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None