Folinic Acid and Vascular Reactivity in HIV

NCT01768182 | Completed DMC

• 1 other identifier: 08035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

folic acid; folates; Vascular Reactivity; HIV

Outcome Measures

Primary Outcomes (1)

• Change in vascular reactivity

  After an overnight fast, the assessments were performed in a temperature-controlled, quiet room, with subjects in the supine position. Throughout the protocol, blood pressure and heart rate were measured in the dominant arm using a calibrated oscillometric automatic device (Dinamap 1846 SX/P; Critikon, Florida, USA). Forearm blood flow was measured by venous occlusion plethysmography (D.E Hokanson, Washington, USA), in the nondominant limb, as previously described. In short, a rapid inflator cuff was used in the upper arm to occlude venous outflow and hand circulation was arrested by placing a cuff around the wrist. Reactive hyperemia was induced by placing a cuff in the upper-arm at 250 mmHg, and releasing after 5 min. After 15 min of rest, 2.5 mg of sublingual isosorbide dinitrate (Isordil®, Sigma, Brazil), was administered as an endothelium-independent vasodilator. Five minutes later, endothelium-independent vasodilatation of the brachial artery was measured.

  at baseline and after 4 weeks

Secondary Outcomes (1)

• Change in Laboratory measurements

  at baseline and after 4 weeks

Study Arms (2)

Folinic Acid

EXPERIMENTAL

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.

Dietary Supplement: Folinic Acid

Placebo

PLACEBO COMPARATOR

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

Interventions

Folinic Acid DIETARY_SUPPLEMENT

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

Folinic Acid

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individual known HIV disease
• aged 18 or over
• on ART for at least 6 months
• undetectable viral load (less than 50 copies/ml)
• CD4 counts more than 200 cells/mm3.

You may not qualify if:

• diabetes mellitus
• any active infection
• liver disease
• renal disease
• history of cardiovascular disease
• uncontrolled hypertension
• pregnancy
• use of illicit drug
• mental illness
• use of tobacco
• taking any dietary supplement (such as folic acid or antioxidants)
• women taking hormone replacement therapy

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Leucovorin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Eduardo Sprinz, ScD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 15, 2013
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

BR (1)