Folinic Acid and Vascular Reactivity in HIV
This study has been completed.
Sponsor:
Hospital de Clinicas de Porto Alegre
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
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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
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 May 19, 2013