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Evaluation of folinic acid supplementation, to prevent dysfunction of blood vessels in patients with HIV and HIV-HCV

Clinical Trial Randomized, Double Blind, Placebo Controlled, of folinic acid supplementation on Endothelial Function in Individuals Infected with HIV and HIV-HCV. - FAST study: Folinic acid: Supplementation and therapy in patients with HIV and HIV-HCV infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9366qc
Enrollment
Unknown
Registered
2014-04-25
Start date
2012-10-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C, Endothelial Dysfunction, Atherosclerosis

Interventions

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. Partici
Dietary supplement
Other
HP3.073.433.101

Sponsors

Fabio Lopes Pedro
Lead Sponsor
Fabio Lopes Pedro
Collaborator

Eligibility

Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: Monoinfected patients by with HIV; or HCV-HIV co-infected; using antiretroviral therapy; who signed an consent form.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactFabio ;Sandra Lopes Pedro;Fuchs

Hospital Universitario de Santa Maria;Hospital de Clinicas de Porto Alegre

fabiopedro.balboa@gmail.com;scfuchs@terra.com.br55--322-08538;51-3359-7695

Outcome results

None listed

Source: REBEC (via WHO ICTRP)