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van CCT (UK)


Lowering of very long chain fatty acids in patients with X-linked adrenoleukodystrophy (X-ALD): A biochemical study.


- candidate number2053
- NTR NumberNTR682
- ISRCTNISRCTN31565393
- Date ISRCTN created22-nov-2006
- date ISRCTN requested8-nov-2006
- Date Registered NTR6-apr-2006
- Secondary IDsMEC05/175 
- Public TitleLowering of very long chain fatty acids in patients with X-linked adrenoleukodystrophy (X-ALD): A biochemical study.
- Scientific TitleLowering of very long chain fatty acids in patients with X-linked adrenoleukodystrophy (X-ALD): A biochemical study.
- ACRONYMLOVA
- hypothesisCholesterol lowering by low fat diet and lovastatin will also reduce very long chain fatty acids in patients with X-ALD.
- Healt Condition(s) or Problem(s) studiedX-linked adrenoleukodystrophy (X-ADL)
- Inclusion criteria1. Male patients with X-ALD (confirmed by biochemical analysis or mutation analysis of the ABCD1 gene); 2. 18 years or older; 3. Able to give informed consent and visit the hospital; 4. No contraindications for use of trial medication.
- Exclusion criteria1. Use of another cholesterol lowering drug; 2. Liver disease or CK more than 3 times baseline level; 3. Use of very long chain fatty acid lowering therapy (e.g. Lorenzo's oil) in the 8 weeks preceding the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type-
- Studytypeintervention
- planned startdate 1-aug-2006
- planned closingdate1-aug-2008
- Target number of participants20
- Interventions1. All patients participating in the trial will comply to a diet (American Heart Association level 1). 2. All patients will receive 6 months of placebo and 6 months of lovastatin 40 mg daily in random order (double blind, crossover design).
- Primary outcomeVery long chain fatty acid levels (in plasma and erythrocytes).
- Secondary outcome
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. M. Engelen
- CONTACT for SCIENTIFIC QUERIESMD. M. Engelen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
European Leukodystrophy Foundation (ELA)
- PublicationsN/A
- Brief summaryIn 1998 Singh et al reported that lovastatin (a cholesterol lowering drug) could reduce very long chain fatty acids in cultured skin fibroblasts from patients with X-ALD. A small open label study showed an effect on plasma VLCFA in some patients, a finding that was not reproduced in a small study with simvastatin. With this randomized double blind placebo controlled cross-over study we aim to systematically study the effect of lovastatin (or more generally cholesterol lowering) on very long chain fatty acids in X-ALD.
- Main changes (audit trail)
- RECORD6-apr-2006 - 4-dec-2006


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