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

Karolinska Institute

Status: Enrolling

Conditions: Open-angle Glaucoma; Pseudoexfoliation Glaucoma

Treatments: Other: Standard Care; Dietary Supplement: Vitamin B-mix

Study type: Interventional

Funder types: Other

Identifiers

NCT06885827

2023-06239-01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

Inclusion Criteria:

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

• 18 years of age or older
• POAG, NTG, or PXFG in one or both eyes diagnosed 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 -12dB in the study eye(s) or threatening central visual field damage (a paracentral point of less than -10dB in either eye within 10 degrees of fixation)
• Eye pressure greater than 35 mmHg in either eye 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin B-mix

Controls

Active Comparator group

Description:

Participants in this arm receive standard glaucoma care only.

Treatment:

Other: Standard Care