Iron Supplements Effect on B-Phe Levels in PKU Patients During 3 Years Study

PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

January 7, 2020

Primary Completion Date

January 9, 2023

Study Completion Date

April 3, 2023

Conditions
Phenylketonuria (PKU)
Interventions
DIETARY_SUPPLEMENT

iron supplementation

"The amount of supplementary iron was decided for patients according to the daily requirement (8- 18 mg / day), according to LARN 2012 and (RDAs) for Iron. (25) . This study took in consideration also, the recommendation of the National Institutes of Health iron dietary supplement fact of sheet as reference to calculate iron dose for our candidates because this dose isn't against LARN and more practical to applicate.~The minimum RDA values is applied, which coincides within the LARN daily requirement limits. (7 mg-18 mg of iron per day). Applying the minimum recommended RDA dose, that can satisfy the daily iron requirement by age, approximating it to be adequate for the clinical dose administered orally once a day (e.g. 1.98 g ==\> 2 g, 1.53 g ==\> 1.5 g"

DIETARY_SUPPLEMENT

control group

Non intervension: Only restricted low and controlled Phe diet therapy

Trial Locations (1)

20142

ASST-Santi Paolo e Carlo, Milan

All Listed Sponsors
collaborator

Università Luigi Vanvitelli della Campania

UNKNOWN

lead

ASST Santi Paolo e Carlo

OTHER

NCT06792240 - Iron Supplements Effect on B-Phe Levels in PKU Patients During 3 Years Study | Biotech Hunter | Biotech Hunter