Folinic Acid and Vascular Reactivity in HIV

This study has been completed.
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Shana Souza Grigoletti, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01768182
First received: January 2, 2013
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Human Immunodeficiency Virus (HIV) Infection
Dietary Supplement: Folinic Acid
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Short-term Folinic Acid Supplementation Improves Vascular Reactivity in HIV-infected Individuals: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Change in vascular reactivity [ Time Frame: at baseline and after 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in Laboratory measurements [ Time Frame: at baseline and after 4 weeks ] [ Designated as safety issue: Yes ]
    All samples were obtained after an overnight fast, before and after 4 weeks of intervention. For each subject, total plasma homocysteine concentration, serum folate, vitamin B12, glucose, creatinine, total cholesterol, high density lipoprotein cholesterol (HDL-C), and triglycerides were measured. Serum folate and vitamin B12 levels were measured by a competitive immunoassay using direct chemiluminescent technology (Bayer ADVIA Centaur, Leverkusen, Germany). Plasma homocysteine levels were also measured by a competitive immunoassay using direct chemiluminescent technology (IMMULITE 2000 Siemens, Illinois, USA). Glucose, creatinine, total cholesterol, HDL-c, and triglycerides were measured with standard laboratory methods.


Enrollment: 30
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
Placebo Comparator: Placebo
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768182

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Director: Eduardo Sprinz, ScD Hospital de Clínicas de Porto Alegre
  More Information

No publications provided

Responsible Party: Shana Souza Grigoletti, Principal Investigator, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01768182     History of Changes
Other Study ID Numbers: 08035
Study First Received: January 2, 2013
Last Updated: January 24, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
folic acid; folates; Vascular Reactivity; HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Leucovorin
Folic Acid
Levoleucovorin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014