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
Protocol serial number	MEC05/175; NTR682
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	European Leukodystrophy Foundation (ELA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M Engelen
Scientific

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

Primary study design	Interventional
Study design	Randomised double-blind placebo controlled crossover trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lovastatin
Primary outcome measure(s)	Very long chain fatty acid levels (in plasma and erythrocytes).
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/08/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	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

Academic Medical Centre (AMC)

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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