Public trial
RBR-9366qc Evaluation of folinic acid supplementation, to prevent dysfunction of blood vessels in patients with HIV and HIV-HCV
Date of registration: 04/25/2014 (mm/dd/yyyy)Last approval date : 04/25/2014 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Clinical Trial Randomized, Double Blind, Placebo Controlled, of folinic acid supplementation on Endothelial Function in Individuals Infected with HIV and HIV-HCV.
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Eficácia da Suplementação com Ácido Folínico sobre a Função Endotelial de Indivíduos Infectados pelo HIV e HIV-HCV: Ensaio Clínico Randomizado Controlado por Placebo
Trial identification
- UTN code: U1111-1134-6632
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Public title:
en
Evaluation of folinic acid supplementation, to prevent dysfunction of blood vessels in patients with HIV and HIV-HCV
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Avaliação da suplementação de acido folinico para prevenir disfunção de vasos sanguíneos em portadores de infecção pelo HIV e HIV-HCV
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Scientific acronym:
en
FAST study
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FAST study
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Public acronym:
en
FAST study
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FAST study
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Secondaries identifiers:
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0533612.8.0000.5346
Issuing authority: Comite de Etica e Pesquisa da Universidade Federal de Santa Maria
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CAE: 00533612.8.0000.5346
Issuing authority: CONEP
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0533612.8.0000.5346
Sponsors
- Primary sponsor: Fabio Lopes Pedro
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Secondary sponsor:
- Institution: Fabio Lopes Pedro
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Supporting source:
- Institution: Hospital Universitario de Santa Maria
- Institution: Hospital de Clinicas de Porto Alegre
Health conditions
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Health conditions:
en
Chronic Hepatitis C, Endothelial Dysfunction, Atherosclerosis
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HIV/AIDS, Hepatite C crônica, Disfunção Endotelial, Aterosclerose HIV / AIDS
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General descriptors for health conditions:
en
A00-B99 I - Certain infectious and parasitic diseases
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A00-B99 I - Algumas doenças infecciosas e parasitárias
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C14 Cardiovascular diseases
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C14 Doenças cardiovasculares
es
C14 Enfermedades cardiovasculares
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Specific descriptors:
Interventions
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Interventions:
en
Experimental group: 35 participants received folinic acid (FA) five (5) milligrams (mg) orally, once daily in the morning, for four weeks. The control group (34 participants) received placebo. Participants were randomized. The placebo tablets and AF are indistinguishable in color, aroma, flavor, shape and size.
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Grupo experimental: 35 participantes receberam ácido folínico (AF) cinco (5) miligramas (mg), via oral, dose única diária pela manhã,durante quatro semanas. O grupo controle (34 participantes) recebeu placebo. Os participantes foram randomizados. Os comprimidos de placebo e de AF serão indistinguíveis em cor, aroma, sabor, forma e tamanho.
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Descriptors:
en
HP3.073.433.101 Placebo Effect
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HP3.073.433.101 Efeito Placebo
es
HP3.073.433.101 Efecto Placebo
en
J02.500.456 Dietary Supplements
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J02.500.456 Suplementos Dietéticos
es
J02.500.456 Suplementos Dietéticos
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 10/20/2012 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 69 - 18 Y 49 Y -
Inclusion criteria:
en
Monoinfected patients by with HIV; or HCV-HIV co-infected; using antiretroviral therapy; who signed an consent form.
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Pacientes monoinfectados pelo HIV; ou coinfectados HIV-HCV; em uso de terapia antirretroviral; que assinarem termo de consentimento informado.
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Exclusion criteria:
en
history of diabetes mellitus; acute myocardial infarction; renal insufficiency (creatinine current> 1.5); stroke; clinical signs and / or laboratory evidence of liver cirrhosis (ascites, hepatic encephalopathy present or recent upper gastrointestinal bleeding, esophageal varices present, liver ultrasound with signs suggestive of cirrhosis, biopsy Metavir F4); current pregnancy; recent use (last 30 days) of: statins, fibrates, hormone replacement therapy, sulfonamides (sulfamethoxazole, sulfadiazine), vitamin supplements, or similar of folinic acid and / or folic acid; Individuals with restriction or inability to understand and decide for their participation in the study.
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com antecedentes de: diabetes mellitus; infarto agudo do miocárdio; insuficiência renal (creatinina atual >1,5); acidente vascular cerebral; sinais clínicos e/ou laboratoriais de cirrose hepática (ascite, encefalopatia hepática atual ou prévia, hemorragia digestiva alta recente, presença de varizes esofágicas, ecografia de fígado com sinais sugestivos de cirrose, biópsia com metavir F4); gestação atual; uso recente (30 dias) de: estatinas, fibratos, terapia de reposição hormonal, sulfonamidas (sulfametoxazol, sulfadiazina), suplementos vitamínicos, ou similares de ácido folínico e/ou ácido fólico; Indivíduos com restrição ou incapacidade de compreender e decidir pela sua participação no estudo.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Prevention Parallel 2 Double-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
The primary endpoint is the vascular response of the brachial artery during reactive hyperemia, as measured by Doppler ultrasound before and after the intervention. The variation of at least 20% of the flow is considered positive outcome.
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O desfecho primário é a resposta vascular de artéria braquial durante a hiperemia reativa, aferida por ecodoppler antes e após a intervenção. A variação de pelo menos 20% do fluxo será considerado desfecho positivo.
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Secondary outcomes:
en
Secondary outcomes are changes in biochemical and hemodynamic variables at baseline and after interventions. Laboratory analysis (serum): homocysteine,folic acid, vitamin B12, creatinine, fasting glucose, cholesterol, (total, high and low density), triglycerides. Will be measured blood pressure, heart rate, weight, height.
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Desfechos secundários serão as alterações de variáveis bioquímicas e hemodinâmicas, em relação aos valores basais obtidos antes das intervenções. Analises laboratoriais (sericas):homocisteina, acido folico, vitamina B12, creatinina, glicose de jejum, colesterol (total, alta e baixa densidade), trigliceridios. Serão aferidas pressão arterial, frequencia cardiaca, peso, estatura.
Contacts
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Public contact
- Full name: Fabio Lopes Pedro
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- Address: Av. Roraima, Predio 22, sala 26, ambulatorio ala 1 - Universidade Federal de Santa Maria
- City: Santa Maria / Brazil
- Zip code: 97105-900
- Phone: 55--322-08538
- Email: fabiopedro.balboa@gmail.com
- Affiliation: Hospital Universitario de Santa Maria
- Full name: Sandra Costa Fuchs
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- Address: Rua Ramiro Barcelos 2350, Centro de Pesquisa Clinica, Estudo Prever, 5 andar
- City: Porto Alegre / Brazil
- Zip code: 90035-003
- Phone: 51-3359-7695
- Email: scfuchs@terra.com.br
- Affiliation: Hospital de Clinicas de Porto Alegre
- Full name: Sandra Cristina Costa Fuchs
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- Address: Rua Ramiro Barcelos 2350 - Centro de Pesquisa Clinica
- City: Porto Alegre / Brazil
- Zip code: 90035-903
- Phone: 51--913-50604
- Email: scfuchs@terra.com.br
- Affiliation: Hospital de Clinicas de Porto Alegre
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Scientific contact
- Full name: Fabio Lopes Pedro
-
- Address: Av. Roraima, Predio 22, sala 26, ambulatorio ala 1 - Universidade Federal de Santa Maria
- City: Santa Maria / Brazil
- Zip code: 97105-900
- Phone: 55--322-08538
- Email: fabiopedro.balboa@gmail.com
- Affiliation: Hospital Universitario de Santa Maria
- Full name: Sandra Costa Fuchs
-
- Address: Rua Ramiro Barcelos 2350, Centro de Pesquisa Clinica, Estudo Prever, 5 andar
- City: Porto Alegre / Brazil
- Zip code: 90035-003
- Phone: 51-3359-7695
- Email: scfuchs@terra.com.br
- Affiliation: Hospital de Clinicas de Porto Alegre
- Full name: Sandra Cristina Costa Fuchs
-
- Address: Rua Ramiro Barcelos 2350 - Centro de Pesquisa Clinica
- City: Porto Alegre / Brazil
- Zip code: 90035-903
- Phone: 51--913-50604
- Email: scfuchs@terra.com.br
- Affiliation: Hospital de Clinicas de Porto Alegre
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Site contact
- Full name: Fabio Lopes Pedro
-
- Address: Av. Roraima, Predio 22, sala 26, ambulatorio ala 1 - Universidade Federal de Santa Maria
- City: Santa Maria / Brazil
- Zip code: 97105-900
- Phone: 55--322-08538
- Email: fabiopedro.balboa@gmail.com
- Affiliation: Hospital Universitario de Santa Maria
- Full name: Sandra Costa Fuchs
-
- Address: Rua Ramiro Barcelos 2350, Centro de Pesquisa Clinica, Estudo Prever, 5 andar
- City: Porto Alegre / Brazil
- Zip code: 90035-003
- Phone: 51-3359-7695
- Email: scfuchs@terra.com.br
- Affiliation: Hospital de Clinicas de Porto Alegre
- Full name: Sandra Cristina Costa Fuchs
-
- Address: Rua Ramiro Barcelos 2350 - Centro de Pesquisa Clinica
- City: Porto Alegre / Brazil
- Zip code: 90035-903
- Phone: 51--913-50604
- Email: scfuchs@terra.com.br
- Affiliation: Hospital de Clinicas de Porto Alegre
Additional links:
Total de Ensaios Clínicos 17440.
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