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Folinic Acid and Vascular Reactivity in HIV

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ClinicalTrials.gov Identifier: NCT01768182
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : January 25, 2013
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Shana Souza Grigoletti, Hospital de Clinicas de Porto Alegre

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


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Infection Dietary Supplement: Folinic Acid Other: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Short-term Folinic Acid Supplementation Improves Vascular Reactivity in HIV-infected Individuals: a Randomized Trial
Study Start Date : August 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Folic Acid HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in vascular reactivity [ Time Frame: at baseline and after 4 weeks ]
    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 :
  1. Change in Laboratory measurements [ Time Frame: at baseline and after 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

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

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