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

NCT06885827 | Recruiting

• 1 other identifier: 2023-06239-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Open-angle Glaucoma; Pseudoexfoliation Glaucoma

Keywords

methyl donor supplementation; glaucoma; neuroprotection; randomized clinical trial; open-label; B6; B9; choline; visual field; optical coherence tomography; electroretinogram

Outcome Measures

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.

  Baseline, third month and twelfth month.

Secondary Outcomes (7)

• Changes to retinal structure

  Baseline, third month and twelfth month.

• Change in Visual Field Index (VFI)

  Baseline, third month, and twelfth month.

• Blood biomarkers

  Baseline, third month and twelfth month.

• Intraocular Pressure (IOP)

  From baseline to twelfth months.

• Change in Best Corrected Visual Acuity (BCVA)

  From baseline to twelfth months.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Participants in this arm receive both the Vitamin B-mix supplement and standard glaucoma care.

Dietary Supplement: Vitamin B-mix

Controls

ACTIVE COMPARATOR

Participants in this arm receive standard glaucoma care only.

Other: Standard Care

Interventions

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.

Intervention

Standard Care OTHER

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

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• St. Erik Eye Hospital: collaborator

Study Sites (2)

St Eriks Ögonsjukhus

Stockholm, Stockholm County, 11251, Sweden

RECRUITING

Karolinska institutet, The Division of Eye and vision.

Stockholm, Stockholm County, 14186, Sweden

NOT YET RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Exfoliation Syndrome; Glaucoma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Iris Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rune Brautaset, Professor of Optometry

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Navid Golpour, Medical doctor

CONTACT

+46737085148; navid.golpour@ki.se

James Tribble, Associate Professor

CONTACT

james.tribble@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 20, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

SE (2)