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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Open-angle Glaucoma Pseudoexfoliation Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type ACTIVE_COMPARATOR

Vitamin B-mix

Intervention Type 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.

Controls

Participants in this arm receive standard glaucoma care only.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Standard Care

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No