Cholesterol lowering by low fat diet and lovastatin will also reduce very long chain fatty acids in patients with X-ALD.
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Very long chain fatty acid levels (in plasma and erythrocytes).
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
Cholesterol lowering by low fat diet and lovastatin will also reduce very long chain fatty acids in patients with X-ALD.
Onderzoeksproduct en/of interventie
1. 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).
Publiek
P.O. Box 22660.
M. Engelen
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662044
M.Engelen@amc.uva.nl
Wetenschappelijk
P.O. Box 22660.
M. Engelen
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662044
M.Engelen@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL623 |
| NTR-old | NTR682 |
| Ander register | : MEC05/175 |
| ISRCTN | ISRCTN31565393 |