Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate if B vitamin substitution have effect on NFL (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected individuals with increased plasma homocysteine

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease

NCT00853879

Parkinson's Disease

TERMINATED NA

Folinic Acid and Vascular Reactivity in HIV

NCT01768182

Human Immunodeficiency Virus (HIV) Infection

COMPLETED NA

VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)

NCT00056225

Alzheimer's Disease

COMPLETED PHASE3

Folinic Acid: Supplementation and Therapy

NCT02810275

HIV Infection HCV Coinfection

COMPLETED PHASE3

Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

NCT00877227

Mild Hyperhomocysteinemia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Triobe

Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months.

Group Type EXPERIMENTAL

Cyanocobalamin

Intervention Type DRUG

Folate

Intervention Type DRUG

Pyridoxine

Intervention Type DRUG

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyanocobalamin

Intervention Type DRUG

Folate

Intervention Type DRUG

Pyridoxine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The ability to understand and give informed consent to participate.
2. HIV-1 infected with stable ART \> 12 months
3. Plasma HIV-RNA \< 50 copies/ml
4. Plasma homocysteine ≥ 12 μmol/L (subjects with \< 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4).
5. Male or female, age 18 or older.

Exclusion Criteria

1. Treatment with trimethoprim-sulfamethoxazole or methotrexate
2. Ongoing B6, B12 or folate substitution
3. Antiepileptic treatment
4. Small bowel or ventricular resection
5. Disturbed absorption in small bowel (Mb Crohn, untreated coeliac disease)
6. Ongoing neurological disease or severe psychiatric disease
7. Any malignant tumor in the history.
8. Severe ongoing infection or opportunistic infection
9. AUDIT \> 7 for men and \> 5 for women
10. MADRS \> 20
11. Significant B12 or folate deficiency that indicate substitution (all subjects will be offered adequate substitution, they will be included in the analysis of secondary endpoint 3 (see 5.4)).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No