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Folinic Acid and Vascular Reactivity in HIV

NCT01768182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-01-25

No results posted yet for this study

Summary

Objective: HIV infected individuals present a cluster of conditions that activate or injure the vascular endothelium. The administration of folates may exert beneficial effects on endothelial function in different populations at risk for cardiovascular disease. The aim of the study was to determine the effects of 4 weeks folinic acid supplementation on forearm vascular responses during reactive hyperemia in HIV-infected people under antiretroviral therapy.

Methods: This was a prospective, randomized, double-blind, placebo-controlled trial to compare the effects of 4 weeks daily ingestion of 5 mg folinic acid (n=15) or placebo (n=15). Participants had to be on anti-retroviral therapy for at least 6 months before enrollment, with undetectable viral load, and CD4 cell count \> 200 cells/mm3. Vascular function was evaluated with venous occlusion plethysmography at baseline and after 4 weeks, for the determination of brachial artery reactive hyperemia, and after isosorbide dinitrate administration

Conditions

  • Human Immunodeficiency Virus (HIV) Infection

Interventions

DIETARY_SUPPLEMENT

Folinic Acid

Participants were randomly assigned to a 4-week treatment with either folinic acid (n=15) or placebo (n=15). The study supplementation regimens consisted of the capsules containing 5 mg of folinic acid or placebo. Participants were provided with 1 bottle, which contained 30 capsules. Subjects were instructed to take 1 capsule daily, in the morning

OTHER

Placebo

The study supplementation regimens consisted of the capsules containing 5 mg of folinic acid or placebo. Participants were provided with 1 bottle, which contained 30 capsules. Subjects were instructed to take 1 capsule daily, in the morning

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Eduardo Sprinz, ScD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01768182 on ClinicalTrials.gov