Lowering Of Very long chain fatty Acids in patients with X-linked adrenoleukodystrophy: a biochemical study

ISRCTN ISRCTN31565393
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

Academic Medical Centre (AMC)
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Study information

Study designRandomised double-blind placebo controlled crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymLOVA
Study objectivesCholesterol 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) studiedX-linked adrenoleukodystrophy (X-ALD)
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Lovastatin
Primary outcome measureVery long chain fatty acid levels (in plasma and erythrocytes).
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/08/2006
Completion date01/08/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants20
Key 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
Key exclusion criteria1. 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 enrolment01/08/2006
Date of final enrolment01/08/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Research organisation

European Leukodystrophy Foundation (ELA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/01/2010 Yes No