Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000127909
Ethics application status
Approved
Date submitted
26/01/2011
Date registered
4/02/2011
Date last updated
21/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cyproheptadine as an appetite stimulant in patients with cystic fibrosis and your effect on gain weight
Scientific title
A randomized, double-blind, placebo-controlled trial cyproheptadine versus a placebo for appetite stimulation in patients with cystic fibrosis
Secondary ID [1] 253468 0
Nil
Universal Trial Number (UTN)
U1111-1119-2162
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 261021 0
Malnutrition 261043 0
Condition category
Condition code
Human Genetics and Inherited Disorders 259160 259160 0 0
Cystic fibrosis
Diet and Nutrition 259183 259183 0 0
Other diet and nutrition disorders
Respiratory 259242 259242 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive cyproheptadine for a period of 12 weeks and the control group will receive placebo for the same period.
In the first week 2mg three times a day
In the next weeks 4mg three times daily

Mode of administration: Syrup with a concentration of 1 ml

The patient gets two bottles:
In the first week, in the intervention group
taking the syrup, where each ml is the concentration of 2 mg of cyproheptadine.
In the rest week, the intervention group takes the syrup has a concentration of 4 mg per ml.
Intervention code [1] 257928 0
Treatment: Drugs
Comparator / control treatment
The control group will syrups with taste and appearance similar to cyproheptadine, but will be placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 262035 0
Weight gain in patients with cystic fibrosis
Timepoint [1] 262035 0
The result will be evaluated by the measurement of weight, height and arm circumference of the skinfolds. Results are expressed as z score and percentile
Secondary outcome [1] 268955 0
To compare the food consumption and nutritional status of patients with cystic fibrosis before and after the intervention, in the intervention and control groups
Timepoint [1] 268955 0
Food consumption is measured by food frequency questionnaire
Secondary outcome [2] 268956 0
Correlate food intake pulmonary function and with nutritional status
Timepoint [2] 268956 0
Will compare the spirometry performed on the first day of treatment and after the twelve weeks

Eligibility
Key inclusion criteria
* patients aged between 5 and 18 years;
* qualified to spirometry;
* weight / age <100%.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with intolerance to antihistamines, patients using sedative or narcotic drugs, patients that have taken appetite stimulants or steroids for 30 days before the study, inability to do spirometry.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The pharmaceutical patients randomized in blocks by Pepi software, to receive placebo or cyproheptadine The researcher who delivered the envelopes to the patients, had no knowledge of its contents because the allocation was concealed in sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3157 0
Brazil
State/province [1] 3157 0
Rio Grande do Sul

Funding & Sponsors
Funding source category [1] 258386 0
University
Name [1] 258386 0
Pontificia Universidade Catolica do Rio Grande do Sul
Country [1] 258386 0
Brazil
Primary sponsor type
Individual
Name
Regina Nejedlo
Address
Rua Mostardeiro, 455
Loja 07
Independencia, Porto Alegre / RS
Cep: 90430-001
Country
Brazil
Secondary sponsor category [1] 257542 0
University
Name [1] 257542 0
Pontificia Universidade Catolica do Rio Grande do Sul
Address [1] 257542 0
Instituto de Pesquisas Biomedicas - IPB
Hospital Sao Lucas
Av Ipiranga, 6690 - 2 andar
Caixa Postal 1429
Porto Alegre - RS - Brasil
CEP 90610-000
Country [1] 257542 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260361 0
Comite de Etica do Hospital Sao Lucas da PUCRS
Ethics committee address [1] 260361 0
Ethics committee country [1] 260361 0
Brazil
Date submitted for ethics approval [1] 260361 0
01/01/2010
Approval date [1] 260361 0
16/04/2010
Ethics approval number [1] 260361 0
10\4985
Ethics committee name [2] 260363 0
Comite de Etica da Irmandade Santa Casa de Misericordia
Ethics committee address [2] 260363 0
Ethics committee country [2] 260363 0
Brazil
Date submitted for ethics approval [2] 260363 0
15/06/2010
Approval date [2] 260363 0
10/08/2010
Ethics approval number [2] 260363 0
311/010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32130 0
Address 32130 0
Country 32130 0
Phone 32130 0
Fax 32130 0
Email 32130 0
Contact person for public queries
Name 15377 0
Larissa da Rosa Feix
Address 15377 0
Faculdade de Medicina da PUCRS
Instituto de Pesquisas Biomedicas - IPB
Hospital Sao Lucas
Av Ipiranga, 6690 - 2 andar
Caixa Postal 1429
Porto Alegre - RS - Brasil
Cep: 90610-000
Country 15377 0
Brazil
Phone 15377 0
+55 (51) 9192.8811
Fax 15377 0
Email 15377 0
larissafeix@hotmail.com
Contact person for scientific queries
Name 6305 0
Renato Tetelbom Stein
Address 6305 0
Instituto de Pesquisas Biomedicas - IPB
Hospital Sao Lucas
Av Ipiranga, 6690 - 2 andar
Caixa Postal 1429
Porto Alegre - RS - Brasil
Cep: 90610-000
Country 6305 0
Brazil
Phone 6305 0
+55 (51) 9972.6224
Fax 6305 0
Email 6305 0
rstein@pucrs.br

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.