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RECRUITING
NCT06885827
NA

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

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-03-31

Completion Date

2027-03-31

Last Updated

2025-04-29

Healthy Volunteers

No

Interventions

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.

OTHER

Standard Care

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

Locations (2)

St Eriks Ögonsjukhus

Stockholm, Stockholm County, Sweden

Karolinska institutet, The Division of Eye and vision.

Stockholm, Stockholm County, Sweden