An interventional study of Vitamin B-mix and Standard Care in Open-angle Glaucoma and Pseudoexfoliation Glaucoma, sponsored by Karolinska Institutet. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
This study aims to determine whether a combination of vitamins (B6, B9, B12, and choline) can help protect the eyes of people with glaucoma and slow vision loss. The study will assess whether these vitamins support retinal cells and maintain or improve their function.
Adults aged 18 and older with primary open-angle glaucoma (including normal-tension glaucoma) or pseudoexfoliation glaucoma, and those with mild to moderate glaucoma, may be eligible. Participants must meet specific medical criteria and cannot take additional vitamin supplements during the study.
Participants will be randomly assigned to one of two groups: one group will take a daily vitamin supplement (B6, B9, B12, and choline) for one year, along with standard glaucoma care, while the other will continue standard care without extra vitamins. The vitamins used are well tolerated at selected doses, with possible mild side effects such as an upset stomach or tingling sensations. They will visit the clinic five times over 12 months (at the start, and at 3, 6, 9, and 12 months) for routine eye tests, including measuring eye pressure, checking vision and visual fields, taking scans of the eye's nerve layers (OCT), and completing an electroretinogram (ERG) to assess retinal function. Blood samples will also be collected.
If the vitamins are effective, this could provide an additional strategy alongside current eye pressure lowering treatments to reduce vision loss.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 80 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Eligibility Criteria
Inclusion Criteria:
Patients with the following characteristics will be eligible for inclusion in the trial:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from participation in the study:
Participants in this arm receive both the Vitamin B-mix supplement and standard glaucoma care.
Dietary Supplement: Vitamin B-mix
Participants in this arm receive standard glaucoma care only.
Other: Standard Care
Daily oral supplementation with: Vitamin B6 (pyridoxine, 25 mg), 1 capsule Vitamin B9 (folic acid, 400 µg) + Vitamin B12 (cyanocobalamin, 1 mg), 2 capsules. Choline (choline bitartrate, 500 mg), 2 capsules Administered alongside standard glaucoma care.
Usual glaucoma management (e.g., monitoring and/or IOP-lowering treatments) without additional supplementation.
Change in photopic negative response (PhNR) on electroretinography (ERG)
The primary outcome is the change in retinal function as measured by the PhNR on ERG over a 12-month period.
Time frame: Baseline, third month and twelfth month.
Changes to retinal structure
Measurement of retinal nerve fiber layer (RNFL) and ganglion cell layer-inner plexiform layer (GCL-IPL) thickness via OCT.
Time frame: Baseline, third month and twelfth month.
Change in Visual Field Index (VFI)
Changes in Visual Field Index (VFI) assessed by automated perimetry. Unit of Measure: Percentage (%).
Time frame: Baseline, third month, and twelfth month.
Blood biomarkers
Analysis of blood metabolomic profiles and global DNA methylation levels to evaluate systemic effects of the intervention.
Time frame: Baseline, third month and twelfth month.
Intraocular Pressure (IOP)
Measured using ICare tonometer.
Time frame: From baseline to twelfth months.
Change in Best Corrected Visual Acuity (BCVA)
Measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. Minimum Value: 0 (worst visual acuity). Maximum Value: 100 (best visual acuity) Interpretation: Higher scores indicate better visual acuity.
Time frame: From baseline to twelfth months.
Change in Mean Deviation (MD)
Changes in Mean Deviation (MD) assessed by automated perimetry. Unit of Measure: Decibels (dB).
Time frame: Baseline, third month, and twelfth month.
Change in Pattern Standard Deviation (PSD)
Changes in Pattern Standard Deviation (PSD) assessed by automated perimetry. Unit of Measure: Decibels (dB)
Time frame: Baseline, third month, and twelfth month.
Plan to share: Undecided — We aim to share pseudonymized individual participant data that underlie results in a publication in accordance with institutional regulations.
No publications or documents are linked to this record.
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