No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
Very long chain fatty acid levels (in plasma and erythrocytes).
Background summary
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.
Study objective
Cholesterol lowering by low fat diet and lovastatin will also reduce very long chain fatty acids in patients with X-ALD.
Intervention
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).
P.O. Box 22660.
M. Engelen
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662044
M.Engelen@amc.uva.nl
P.O. Box 22660.
M. Engelen
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662044
M.Engelen@amc.uva.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL623 |
| NTR-old | NTR682 |
| Other | : MEC05/175 |
| ISRCTN | ISRCTN31565393 |