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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000535370
Ethics application status
Approved
Date submitted
24/09/2008
Date registered
22/10/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase IV study, randomized, placebo-controlled for the evaluation of efficacy and tolerability of arginine aspartate in patients with moderate to severe fatigue
Scientific title
Phase IV study, randomized, placebo-controlled for the evaluation of efficacy and tolerability of arginine aspartate in patients with moderate to severe fatigue
Secondary ID [1] 252340 0
Not aplicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe fatigue 3737 0
Condition category
Condition code
Other 3913 3913 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arginine aspartate 250mg administration orally during 60 days, 2 tablets twice a day (after breakfeast and after dinner)
Intervention code [1] 3452 0
Treatment: Drugs
Comparator / control treatment
Placebo (the same substances except for arginine aspartate) administration orally during 60 days, 2 tablets twice a day (after breakfeast and after dinner)
Control group
Placebo

Outcomes
Primary outcome [1] 4811 0
Clinical evaluation measured by the Piper scale
Timepoint [1] 4811 0
Evaluation will be measured in screening - visit 1 (7 days before baseline), baseline - visit 2 (day = 0), visit 3 (day =30), visit 4 (day = 60 - end of treatment period)
Secondary outcome [1] 8118 0
Tolerability measured by patient adverse event reports (Serious and non serious adverse event). Arginine aspartate rarely presents alergic reactions or other adverse event, however every single adverse event presented during the study (81 days - screening, treatment period and follow up period) will be followed. The adverse events will be assessed by patient reports during each study visit and/or patient contact at any time. Non serious adverse events will be recorded at the Case Report Form (CRF) and serious adverse events will be recorded at a special serious adverse event report form (e.g. Council for International Organizations of Medical Sciences (CIOMS)
Timepoint [1] 8118 0
During all study - 81 days (baseline - 7 days, treatment period - 60 days and follow up period - 14 days)

Eligibility
Key inclusion criteria
Patients between 18 to 70 years old
Informed consent
Rate = or more than 4 in the Piper Scale
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnants
Depression
Organic disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1233 0
Brazil
State/province [1] 1233 0

Funding & Sponsors
Funding source category [1] 3917 0
Commercial sector/Industry
Name [1] 3917 0
Nikkho Zydus
Address [1] 3917 0
Rua Jaime Perdigao, 431- Rio de Janeiro
Country [1] 3917 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Nikkho Zydus
Address
Rua Jaime Perdigão 431- Rio de Janeiro
Country
Brazil
Secondary sponsor category [1] 3514 0
None
Name [1] 3514 0
Address [1] 3514 0
Country [1] 3514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5980 0
Federal University of Sao Paulo
Ethics committee address [1] 5980 0
Ethics committee country [1] 5980 0
Brazil
Date submitted for ethics approval [1] 5980 0
Approval date [1] 5980 0
Ethics approval number [1] 5980 0

Summary
Brief summary
Fatigue is a very frequent symptom and is present in 50% of patients that seek a doctor’s appointment.
Fatigue could be defined as an oppressive feeling, sustained by exhaustion and reduced capacity of physical and mental works on the habitual level. Its defining characteristics include signs and symptoms that are linked to the control of body energy, to difficulty in doing daily normal activities, to verbalization of extreme exhaustion, and contribute to generation and establishment of lack of concentration, lack of interest, reduced libido and a feeling of guilt for not playing expected social roles.
The L-arginin is a precursor in the synthesis of Nitric Oxide (NO). This Oxide is a molecule that plays different roles in the body. Among them is the stimulation of the immunological response mediated by lymphocytes and macrophages; the reduction of the blood platelet hiperaggregation and the maintenance of vascular tonus in the regulation of arterial pressure, that involves the dynamic equilibrium between NO and endothelins.
The L-arginin is a semi-essential aminoacid produced by the body, although it is not an enough production for all what is needed for.
The arginin aspartate can also decrease fatigue and acts in several types of asthenia, strengthening the muscular capacity and having a support role in the treatment of various processes including the ones caused by stress.
In prolonged administration of arginin, there is an increase in the production of Nitric Oxide, and its supplementation has been related to an improvement of the contractile function of the skeletal muscle. The hypothesis that this improvement in muscular strength occurs in the short term has been related to the vasodilator effect of the NO with consequent improvement of muscular perfusion.
If we take into consideration that fatigue is a sufficiently important symptom to compromise the quality of life, leading a person to feel limited in dealing with her daily chores since once she initiates her activities, she can feel tired prematurely; supplementation with arginin would increase the production of NO with improvement of muscular response to the daily life activities, this way, decreasing the intensity or even eliminating the symptom fatigue.
The objective of this study is to find fatigue descrease by Piper Scale. The classification of the Piper scale has to decrease after 60 days of treatment comparing to basal classification (before treatment).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28968 0
Address 28968 0
Country 28968 0
Phone 28968 0
Fax 28968 0
Email 28968 0
Contact person for public queries
Name 12125 0
Tatiana Ferian da Fonseca
Address 12125 0
Rua Borges Lagoa 1080- conj.101
São Paulo
Country 12125 0
Brazil
Phone 12125 0
55.11.59044454
Fax 12125 0
55.11.50837848
Email 12125 0
tatiana@newcotrials.com
Contact person for scientific queries
Name 3053 0
Tatiana Ferian da Fonseca
Address 3053 0
Rua Borges Lagoa, 1080- conj.101
São Paulo
Country 3053 0
Brazil
Phone 3053 0
55.11.59044454
Fax 3053 0
55.11.50837848
Email 3053 0
tatiana@newcotrials.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary