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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

Study Description
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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

Condition or disease Intervention/treatment Phase
HIV Drug: Cyanocobalamin Drug: Folate Drug: Pyridoxine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Vitamin B Substitution on Plasma NFL and Neurocognitive Performance in HIV-infected Individuals With Increased Plasma Homocysteine
Study Start Date : April 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Cyanocobalamin
Drug: Folate
Drug: Pyridoxine
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. Declining NFL or decreased rate of increase of NFL [ Time Frame: One year ]

Eligibility Criteria
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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:

  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.)
Contacts and Locations
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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): NCT02773147


Contacts
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Contact: Magnus Gisslén, MD, PhD +46313436238 magnus.gisslen@infect.gu.se

Locations
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Sweden
Department of Infectious Diseases, Sahlgrenska university hospital Recruiting
Gothenburg, Sweden
Contact: Magnus Gisslén, MD, PhD    +46313436238    magnus.gisslen@infect.gu.se   
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Magnus Gisslén, MD, PhD Göteborg University
More Information
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02773147    
Other Study ID Numbers: 2015-004311-20
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Pyridoxine
Vitamin B 12
Hydroxocobalamin
Hematinics
Vitamin B Complex
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs