Health TrialsbyHealthPanel

Vitamin Mix (B6, B9, B12, And Choline) For Glaucoma Patients

ConditionsOpen-angle GlaucomaPseudoexfoliation Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older at the time of inclusion

Diagnosis of Primary Open-Angle Glaucoma (POAG), Normal Tension-Glaucoma (NTG) or Pseudoexfoliation Glaucoma (PEXG) in one or both eyes diagnosticed by an ophthalmologist.

Best corrected Snellen VA of 0.3 or better in the study eye(s)

Two or more reliable VF tests with less than 15% false positives

Disqualifiers

Visual field damage worse than -16dB in the study eye(s)

Eye pressure greater than 35 mmHg in study eye(s) on either of two measurement occasions or a mean pressure of 30 mmHg over two occasions

Any disease affecting retinal function

Neurological or other non-glaucomatous conditions that may affect the visual field

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin B-mix

    Dietary supplement

    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.

  • Standard Care

    Other intervention

    Usual glaucoma management (e.g., monitoring and/or IOP-lowering treatments) without additional supplementation.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: ControlsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

Intraocular Pressure (IOP)

Measured using ICare tonometer.

Time frame
From baseline to twelfth months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

St. Erik Eye Hospital

Collaborator

Source ClinicalTrials.gov
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