Prescribed intake of micronutrients and fatty acids in patients with phenylketonuria, and effects on blood micronutrient and fatty acid levels, bone mass and bone turnover.

Prescribed intake of micronutrients and fatty acids in patients with phenylketonuria, and effects on blood micronutrient and fatty acid levels, bone mass and bone turnover. - Intake and effects of micronutrients and fatty acids in patients with PKU.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38467

Enrollment

Registered

2013-04-18

Start date

2013-05-23

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Phenylketonuria PKU

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: This study includes patients with PKU, age of 1 year and older, diagnosed by newborn screening and treated with a protein restricted diet with supplementation of an amino acid mixture, recruited from three academic metabolic centers in the Netherlands. Patients treated with sapropterin are also included, with or without dietary treatment.

Exclusion criteria

Exclusion criteria: Significant changes in the type or amount of amino acid supplements used, within one month before the inclusion date. Pregnancy.

Design outcomes

Primary

Measure	Time frame
- To asses the prescribed micronutrient and fatty acid intake of patients with PKU treated with a protein restricted diet with supplementation of amino acids in a mixture with vitamins and minerals, or sapropterin. - To correlate the prescribed intake of micronutrients and fatty acids from the diet supplemented with an amino acid mixture, or sapropterin, to blood levels of micronutrients and fatty acids.	—

Measure

Time frame

- To asses the prescribed micronutrient and fatty acid intake of patients with PKU treated with a protein restricted diet with supplementation of amino acids in a mixture with vitamins and minerals, or sapropterin. - To correlate the prescribed intake of micronutrients and fatty acids from the diet supplemented with an amino acid mixture, or sapropterin, to blood levels of micronutrients and fatty acids.

—

Secondary

Measure	Time frame
- To assess the BMD and bone turnover in patients with PKU treated with a protein restricted diet with supplementation of amino acids in a mixture with vitamins and minerals, or sapropterin. - To correlate the prescribed intake of micronutrients and fatty acids from a protein restricted diet supplemented with an amino acid mixture, or sapropterin, to BMD and bone turnover. - To correlate blood levels of micronutrients and fatty acids in patients with phenylketonuria to BMD and bone turnover.	—

Measure

Time frame

- To assess the BMD and bone turnover in patients with PKU treated with a protein restricted diet with supplementation of amino acids in a mixture with vitamins and minerals, or sapropterin. - To correlate the prescribed intake of micronutrients and fatty acids from a protein restricted diet supplemented with an amino acid mixture, or sapropterin, to BMD and bone turnover. - To correlate blood levels of micronutrients and fatty acids in patients with phenylketonuria to BMD and bone turnover.

—

Countries

Netherlands

Outcome results