Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000982718
Ethics application status
Approved
Date submitted
29/08/2013
Date registered
3/09/2013
Date last updated
3/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of alpha-lipoic acid supplementation in patients with schizophrenia
Scientific title
Investigation of alpha-lipoic acid supplementation on oxidative stress parameters in patients with schizophrenia
Secondary ID [1] 283112 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 289959 0
Metabolic sindrome 289960 0
Cardiovascular disease 289961 0
Condition category
Condition code
Mental Health 290330 290330 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the effect of alpha lipoic acid (LA) in patients with schizophrenia treated with antipsychotics drugs. In this open label, interventional study we will investigate LA effects (capsule with 500 mg LA, once day 30 min before meals for 90 days) on oxidative stress markers and antioxidative defence in patients with schizophrenia and compared to healthy controls. We hypothesize that LA will effects on increased oxidative stress in schizophrenia, as well as improve some metabolic risk factors, that are resulting in side effects of antipsychotic use. Compliance measured through the number of returned capsules.
Intervention code [1] 287834 0
Treatment: Other
Intervention code [2] 287835 0
Prevention
Comparator / control treatment
The active healthy control group underwent
the exact same treatment (500 mg LA, once day 30 min before meals for 90 days) as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 290368 0
Effects of alpha-lipoic acid supplementation on oxidative stress (plasma superoxide anion levels, serum thiobarbituric acid-reacting substances concentrations, plasma advanced oxidation protein products levels, serum total oxidative status levels, serum proxidative-antioxidative balance levels) and antioxidative defence markers : plasma (superoxide dismutase) and erythrocyte antioxidant enzyme acitivities ( superoxide dismutase, glutathione peroxidase, catalase), total glutathione concentrations in erythrocytes, plasma total sulfhydryl groups, serum total antioxidant status, plasma PON1 actiivity
Timepoint [1] 290368 0
All measurements were done at the point of the study start, after 45 days of supplementation with LA, and after 90 days of supplementation.
Secondary outcome [1] 304364 0
Effects of alpha-lipoic acid supplementation on metabolic risk factors
Anthropometric measurements: weight and height were measured using a calibrated stadiometer and a balance beam scale , % body fat (bioimpedance analysis), waist and hip circumference were measured with a flexible tape.
Systolic and diastolic blood pressures were measured with a standard mercury sphygmomanometer
Laboratory analysis: plasma fasting glucose level and serum lipid status parameters [total cholesterol (t-C), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), triglycerides (TG)]
Timepoint [1] 304364 0
All measurements were done at the point of the study start, after 45 days of supplementation with LA, and after 90 days of supplementation.

Eligibility
Key inclusion criteria
A ICD 10 diagnosis of schizophrenia
Ability to give assent
All patients on stable dose of antipsychotic drugs
Otherwise medically stable

Inclusion criteria for healthy controls were absence of any psychiatric and somatic disease.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of substance abuse or dependence
Several medical disorders: severe head injury, seizure disorders diabetes, cancer, renal or liver diseases, pregnancy
Oral contraceptives, hormone replacement therapy, hypolipidemic drugs, any food supplements at least 30 days before and during the study.
Patients clinically unstable on current medication regimen

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Combination single group and parallel design study:
different groups of participants receive same interventions during the three months period
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
21/04/2011
Date of last participant enrolment
Anticipated
1/05/2012
Actual
12/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 5348 0
Serbia and Montenegro
State/province [1] 5348 0
Belgrade

Funding & Sponsors
Funding source category [1] 287865 0
University
Name [1] 287865 0
University of Belgrade
Faculty of Pharmacy
Country [1] 287865 0
Serbia and Montenegro
Primary sponsor type
University
Name
University of Belgrade, Faculty of Pharmacy
Address
Vojvode Stepe 450
11 000 Belgrade
Country
Serbia and Montenegro
Secondary sponsor category [1] 286594 0
None
Name [1] 286594 0
Address [1] 286594 0
Country [1] 286594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289809 0
The Ethical Committee of the Clinical Centre of Serbia
Ethics committee address [1] 289809 0
Clinical Centre of Serbia,
Pasterova 2
11000 Belgrade
Ethics committee country [1] 289809 0
Serbia and Montenegro
Date submitted for ethics approval [1] 289809 0
02/11/2010
Approval date [1] 289809 0
21/01/2011
Ethics approval number [1] 289809 0

Summary
Brief summary
Increasing evidence suggested that oxidative stress exists in schizophrenia. Oxidative stress also has been indicate to contribute to metabolic syndrome and related disorders, including diabetes and cardiovascular disease, which are higher prevalence in schizophrenia compared to general population. Alpha-lipoic acid is a naturally occurring compound that is synthesized in small amounts by humans. It is found in spinach, potatoes, broccoli, red meats and liver. Orally supply alpha-lipoic acid has potent antioxidant activity. Beside, quenching free radicals, there is evidence that alpha-lipoic acid lead to regeneration endogenous antioxidants such as vitamins C and E, and GSH. Alpha-lipoic acid has been reported to has beneficial effect in many disease associated with increased oxidative stress, which could be a consequence of either increased production of free radicals or reduced antioxidant defenses.We hypothesized that LA would effects on increased oxidative stress in schizophrenia, as well as improved some metabolic risk factors, that are resulting in side effects of antipsychotic use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42546 0
Miss Bojana Vidovic
Address 42546 0
University of Belgrade
Faculty of Pharmacy
Department of Bromatology
Vojvode Stepe 450,
11221 Belgrade
Country 42546 0
Serbia and Montenegro
Phone 42546 0
+381 11 3951-395
Fax 42546 0
Email 42546 0
[email protected]
Contact person for public queries
Name 42547 0
Bojana Vidovic
Address 42547 0
University of Belgrade
Faculty of Pharmacy
Department of Bromatology
Vojvode Stepe 450,
11221 Belgrade
Country 42547 0
Serbia and Montenegro
Phone 42547 0
+381 11 3951-395
Fax 42547 0
Email 42547 0
[email protected]
Contact person for scientific queries
Name 42548 0
Bojana Vidovic
Address 42548 0
University of Belgrade
Faculty of Pharmacy
Department of Bromatology
Vojvode Stepe 450,
11221 Belgrade
Country 42548 0
Serbia and Montenegro
Phone 42548 0
+381 11 3951-395
Fax 42548 0
Email 42548 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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