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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Open-angle Glaucoma; Pseudoexfoliation Glaucoma
• Intervention / Treatment: Other: Standard Care; Dietary supplement: Vitamin B-mix

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Navid Golpour, Medical doctor; Phone Number: +46737085148; Email: navid.golpour@ki.se
• Study Contact Backup: Name: James Tribble, Associate Professor; Email: james.tribble@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 11251
    • Recruiting
    • St Eriks Ögonsjukhus
    • Contact: Navid Golpour, Medical doctor; Phone Number: +46737085148; Email: navid.golpour@ki.se
    • Contact: James Tribble, BSc, PhD.
    • Principal Investigator: Rune Brautaset, Bsc, PhD, Professor.
  • Stockholm, Sweden, 14186
    • Not yet recruiting
    • Karolinska institutet, The Division of Eye and vision.
    • Principal Investigator: Rune Brautaset, Professor of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Participants in this arm receive both the Vitamin B-mix supplement and standard glaucoma care.	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.
Active Comparator: Controls; Participants in this arm receive standard glaucoma care only.	Other: Standard Care; Usual glaucoma management (e.g., monitoring and/or IOP-lowering treatments) without additional supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, third month and twelfth month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes to retinal structure	Measurement of retinal nerve fiber layer (RNFL) and ganglion cell layer-inner plexiform layer (GCL-IPL) thickness via OCT.	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 (%).	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.	Baseline, third month and twelfth month.
Intraocular Pressure (IOP)	Measured using ICare tonometer.	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.	From baseline to twelfth months.
Change in Mean Deviation (MD)	Changes in Mean Deviation (MD) assessed by automated perimetry. Unit of Measure: Decibels (dB).	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)	Baseline, third month, and twelfth month.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: St. Erik Eye Hospital
• Investigators: Principal Investigator: Rune Brautaset, Professor of Optometry, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: open-label; optical coherence tomography; glaucoma; neuroprotection; randomized clinical trial; visual field; electroretinogram; choline; B6; methyl donor supplementation; B9
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Ocular Hypertension; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex
• Other Study ID Numbers: 2023-06239-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We aim to share pseudonymized individual participant data that underlie results in a publication in accordance with institutional regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No