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Evaluation of the effectiveness of low protein and low phenylalanine products (Zarmacaron) in the diet of people with phenylketonuria

Comparison of the effect of low protein pasta with regular pasta on blood phenylalanine levels in children with phenylketonuria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210427051104N1
Enrollment
30
Registered
2021-06-26
Start date
2021-07-23
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

phenylketonuria. Classical phenylketonuria

Interventions

Intervention 1: Intervention group: first receives the standard diet with low phenylalanine pasta and then the standard diet without diet products ---The first group uses the standard phenylketonuria

Sponsors

Alborz University of Medical Sciences
Lead Sponsor
Zarmacaron
Collaborator

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children with phenylketonuria

Exclusion criteria

Exclusion criteria: Reluctance to consume pasta Suffering from other underlying diseases Taking KUVAN drug Parents' dissatisfaction with participation in the research project

Design outcomes

Primary

MeasureTime frame
Phenylalanine. Timepoint: Day 0, 7, 14 and 21 of intervention. Method of measurement: High Performance Liquid Chromatography.

Secondary

MeasureTime frame
Diet compliance and satisfaction. Timepoint: Day 0, 7, 14 and 21 of intervention. Method of measurement: Questionnaire.;Body composition. Timepoint: Day 0, 7, 14 and 21 of intervention. Method of measurement: Body analyzer - Inbody270.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoda Derakhshanian

Alborz University of Medical Sciences

h.derakhshanian@abzums.ac.ir+98 21 4609 6094

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026