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

Official title

Interventional Vitamin Mix Glaucoma Study (IVMGS) - A Prospective, Randomized, Two-Arm, Single-Center Study Protocol in Existing Glaucoma Patients.

Overview

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.

Interventions

• Dietary supplement Vitamin B-mix
  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.
• Other Standard Care
  Usual glaucoma management (e.g., monitoring and/or IOP-lowering treatments) without additional supplementation.

Primary outcome measures

• Change in photopic negative response (PhNR) on electroretinography (ERG) [Time frame: Baseline, third month and twelfth month.]

Secondary outcome measures (7)

• Changes to retinal structure [Time frame: Baseline, third month and twelfth month.]
• Change in Visual Field Index (VFI) [Time frame: Baseline, third month, and twelfth month.]
• Blood biomarkers [Time frame: Baseline, third month and twelfth month.]
• Intraocular Pressure (IOP) [Time frame: From baseline to twelfth months.]
• Change in Best Corrected Visual Acuity (BCVA) [Time frame: From baseline to twelfth months.]
• Change in Mean Deviation (MD) [Time frame: Baseline, third month, and twelfth month.]
• Change in Pattern Standard Deviation (PSD) [Time frame: Baseline, third month, and twelfth month.]

Eligibility criteria

Eligibility Criteria

Inclusion criteria

Patients with the following characteristics will be eligible for inclusion in the trial:

• 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

Exclusion criteria

Patients who meet any of the following criteria will be excluded from participation in the study:

• 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
• Inability to perform visual field examination
• Unwillingness to stop any intake of multivitamins or B vitamin substances
• Known allergy or intolerance to B-vitamins
• Previous eye surgery, except for uncomplicated cataract surgery
• Pregnant or breastfeeding women
• Women of childbearing potential who do not use reliable contraception
• Any disease or condition likely to prevent long-term follow-up
• Cancer diagnosis within the last 5 years (except treated squamous cell carcinoma)
• History of liver disease or stomach ulcers
• Inability to understand and speak Swedish or English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Sweden · 2 centers

• St Eriks Ögonsjukhus — Stockholm
• Karolinska institutet, The Division of Eye and vision. — Stockholm

Publications

• Golpour N, Hui F, Nilsson M, Svensson J, Brautaset RL, Tribble JR, Williams PA. Interventional Vitamin Mix Glaucoma Study (IVMGS): study protocol for a prospective, randomized, two-arm, single-center trial in existing glaucoma patients. Trials. 2025 Oct 13;26(1):403. doi: 10.1186/s13063-025-09168-z. PMID 41084053

Identifiers

NCT: NCT06885827 · 2023-06239-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗