Efficacy of genestein as food supplement in patients with the Sanfilippo syndrome (an extension study).

Efficacy of genestein as food supplement in lpatienst with the Sanfilippo syndrome (an extension study).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22208

Enrollment

Registered

2010-07-05

Start date

2010-07-12

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Sanfilippo syndrome (MPS III)

Interventions

During a 12 month period all particpating patients will receive genestein as food supplement. Genestein dose will be calculated according to the weight of the patients (10 mg/kg/day). The start assess

Eligibility

Inclusion criteria

Inclusion criteria: Patients participated in the initial double blind placebo controlled study on the effect of genestein in a cross-over design.

Exclusion criteria

Exclusion criteria: The parent or legal representative is unwilling to participate.

Design outcomes

Primary

Measure	Time frame
Does genestein significantly decrease urinary GAGs (in particular heparan sulphate) excretion in Sanfilippo patients?	—

Secondary

Measure	Time frame
1. Does genestein decrease serum heparan sulphate concentration? 2. Does genestein decrease accumulation of heparan sulphate in skin biopsies? 3. Does hair morphology improve in MPS III patients using genestein? 4. What is the effect of genestein on behaviour? 5. Does genestein improve neurocognitive outcome?	—

Contacts

Public ContactF.A. Wijburg

f.a.wijburg@amc.uva.nl+31 (0)20 5668890

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)