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

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ClinicalTrials.gov Identifier: NCT02773147
Recruitment Status : Unknown
Verified December 2017 by Göteborg University.
Recruitment status was:  Recruiting
First Posted : May 16, 2016
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Tracking Information
First Submitted Date  ICMJE May 12, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date January 2, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
Declining NFL or decreased rate of increase of NFL [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin B on Plasma Neurofilament Light Protein (NFL) in HIV-infected Individuals With Increased Plasma Homocysteine
Official Title  ICMJE Effect of Vitamin B Substitution on Plasma NFL and Neurocognitive Performance in HIV-infected Individuals With Increased Plasma Homocysteine
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE
  • Drug: Cyanocobalamin
  • Drug: Folate
  • Drug: Pyridoxine
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Cyanocobalamin
    • Drug: Folate
    • Drug: Pyridoxine
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 13, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)).
  12. Pregnancy at screening visit, or planning pregnancy during study period is an exclusion criteria. (Not due to toxicity of Triobe, but to elevated risk of being prescribed B-vitamins outside of trial. If study object gets pregnant during study, she can continue the study but must be excluded if she starts treatment with other B-vitamin treatment than Triobe.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773147
Other Study ID Numbers  ICMJE 2015-004311-20
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Magnus Gisslén, MD, PhD Göteborg University
PRS Account Göteborg University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP