Lowering Of Very long chain fatty Acids in patients with X-linked adrenoleukodystrophy: a biochemical study
ISRCTN | ISRCTN31565393 |
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DOI | https://doi.org/10.1186/ISRCTN31565393 |
Secondary identifying numbers | MEC05/175; NTR682 |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 29/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M Engelen
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Study information
Study design | Randomised double-blind placebo controlled crossover trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | LOVA |
Study objectives | Cholesterol lowering by low fat diet and lovastatin will also reduce very long chain fatty acids in patients with X-linked adrenoleukodystrophy (X-ALD). |
Ethics approval(s) | Received from the local medical ethics committee |
Health condition(s) or problem(s) studied | X-linked adrenoleukodystrophy (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 six months of placebo and six months of lovastatin 40 mg daily in random order (double blind, crossover design) |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Lovastatin |
Primary outcome measure | Very long chain fatty acid levels (in plasma and erythrocytes). |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/08/2006 |
Completion date | 01/08/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Male |
Target number of participants | 20 |
Key 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 |
Key exclusion criteria | 1. Use of another cholesterol lowering drug 2. Liver disease or creatine kinase (CK) more than three times baseline level 3. Use of very long chain fatty acid lowering therapy (e.g. Lorenzo's oil) in the eight weeks preceding the study |
Date of first enrolment | 01/08/2006 |
Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Website | http://www.amc.nl/ |
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https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
European Leukodystrophy Foundation (ELA)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 21/01/2010 | Yes | No |