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Effect of kuvan on relaxation of diet in phenylketonuria

Effectiveness of Tetrahydrobiopterin for improvement of dietary regimen of children with Phenylketonuria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016100230082N1
Enrollment
20
Registered
2017-06-01
Start date
2015-01-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

mild phenylketonuria. Other hyperphenylalaninaemias

Interventions

Kuvan,100 mg oral tablet, daily, 20 mg/kg. Phenylalanine, orally powder, daily, 50 mg (additive phenylalanine of dietary regime), If level of Phe is normal, another 50 mg of Phe is added for next wee
Treatment - Drugs
Kuvan,100 mg oral tablet, daily, 20 mg/kg. Phenylalanine, orally powder, daily, 50 mg (additive phenylalanine of dietary regime), If level of Phe is normal, another 50 mg of Phe is added for next we

Sponsors

Mashhad University of Medical Sciences, Vice Chancellor for Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with controlled PKU; age range of 1-10 years; lack of underlying disorders (e.g. malnutrition, hepatic and renal diseases). Exclusion criteria: BH4 deficiency; Phe levels less than 600 micromoles/liter or more than 1200 micromoles/liter; presence of fever or acute illness; intolerance to BH4 therapy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum levels of phenylalanine. Timepoint: In first phases, after three days of free diet, then 24 and 48 houres after prescription of BH4. In second phase, measured weekly. Method of measurement: HPLC.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Vajihe Chalak

Mashhad University of Medical Sciences

drvch1380@yahoo.com+98 51 3859 3045

Outcome results

None listed

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