Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06885827

Vitamin Mix (B6, B9, B12, And Choline) For 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Open-angle Glaucoma Exfoliation Syndrome Eye Diseases Glaucoma Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Pseudoexfoliation Glaucoma Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska institutet, The Division of Eye and vision., Stockholm, Stockholm County, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Change in photopic negative response (PhNR) on electroretinography (ERG)

    Time frame: Baseline, third month and twelfth month.

    The primary outcome is the change in retinal function as measured by the PhNR on ERG over a 12-month period.

Secondary outcomes

  1. Changes to retinal structure

    Time frame: Baseline, third month and twelfth month.

    Measurement of retinal nerve fiber layer (RNFL) and ganglion cell layer-inner plexiform layer (GCL-IPL) thickness via OCT.

  2. Change in Visual Field Index (VFI)

    Time frame: Baseline, third month, and twelfth month.

    Changes in Visual Field Index (VFI) assessed by automated perimetry. Unit of Measure: Percentage (%).

  3. Blood biomarkers

    Time frame: Baseline, third month and twelfth month.

    Analysis of blood metabolomic profiles and global DNA methylation levels to evaluate systemic effects of the intervention.

  4. Intraocular Pressure (IOP)

    Time frame: From baseline to twelfth months.

    Measured using ICare tonometer.

  5. Change in Best Corrected Visual Acuity (BCVA)

    Time frame: From baseline to twelfth months.

    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.

  6. Change in Mean Deviation (MD)

    Time frame: Baseline, third month, and twelfth month.

    Changes in Mean Deviation (MD) assessed by automated perimetry. Unit of Measure: Decibels (dB).

  7. Change in Pattern Standard Deviation (PSD)

    Time frame: Baseline, third month, and twelfth month.

    Changes in Pattern Standard Deviation (PSD) assessed by automated perimetry. Unit of Measure: Decibels (dB)

Study contacts

Contact information is provided by the study sponsor or research team.

James Tribble, Associate Professor

CONTACT

[email protected]

Navid Golpour, Medical doctor

CONTACT

[email protected]

+46737085148

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • St. Erik Eye Hospital

Registry information

Official study title

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

Acronym: IVMGS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.