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NCT03058848: PKU Start
Evaluation of PKU Start
NA trial testing PKU Start in Phenylketonuria in 10 participants. Completed in 15 September 2017.
15 September 2017
Quick facts
| Lead sponsor | Vitaflo International, Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 6 March 2017 |
| Primary completion | 15 September 2017 |
| Estimated completion | 15 September 2017 |
| Sites | 3 locations across United Kingdom |
Drugs / interventions tested
- PKU Start
Conditions studied
- Phenylketonuria — all drugs for Phenylketonuria →
- Inborn Errors of Metabolism — all drugs for Inborn Errors of Metabolism →
Sponsor
Vitaflo International, Ltd
Who can join
Adults 4 Weeks to 2, any sex, with Phenylketonuria or Inborn Errors of Metabolism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new Phe free protein substitute for the dietary management of PKU in infants from birth.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03058848
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Phenylketonuria
Currently open trials in the same condition.
- NCT06971731 — A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU) · Phase 3 · recruiting
- NCT07526909 — Effect of Different Meal Types Given Before Exercise on Plasma Amino Acid Levels and Metabolic Control Parameters in Cla · NA · recruiting
- NCT06941532 — GMP Powdered Substitutes in PKU and TYR · NA · recruiting
- NCT06901323 — Effect of L-carnitine Supplementation on Phenylalanine and Brain-derived Neurotrophic Factor Levels in Infants and Child · Phase 4 · active not recruiting
- NCT06302348 — A Study of Sepiapterin in Participants With Phenylketonuria (PKU) · Phase 3 · recruiting
Other Vitaflo International, Ltd trials
Trials by the same sponsor.
- NCT05995717 — Evaluation of PKU UP · NA · active not recruiting
- NCT04898829 — Evaluation of PKU Explore France · NA · completed
- NCT04761588 — Evaluation of TYR Sphere in France · NA · completed
- NCT05096988 — Evaluation of PKU Sphere Liquid · NA · completed
- NCT05051657 — Evaluation of the Express Plus Range · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03058848 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vitaflo International, Ltd
- Last refreshed: 16 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03058848.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing