RecruitingNot ApplicableNCT06885827

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

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


Sponsor

Karolinska Institutet

Enrollment

80 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of B vitamins (B6, B9/folate, B12) and choline — nutrients involved in nerve cell health — can slow vision loss in people with glaucoma, a condition where pressure or other factors damage the optic nerve. **You may be eligible if...** - You are 18 or older - You have been diagnosed with open-angle glaucoma, normal tension glaucoma, or pseudoexfoliation glaucoma in one or both eyes - Your vision in the study eye is at least 0.3 on the Snellen chart (able to read large letters) - You have had at least two reliable visual field tests **You may NOT be eligible if...** - Your vision loss is already severe (worse than -16 dB on visual field testing) - Your eye pressure is very high (above 35 mmHg) - You have retinal disease, neurological conditions affecting vision, or other eye disease - You are already taking B vitamin or multivitamin supplements and unwilling to stop - You are pregnant or breastfeeding - You have a history of liver disease or stomach ulcers - You have had a cancer diagnosis in the past 5 years (except treated squamous cell carcinoma) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTVitamin 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.

OTHERStandard 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

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NCT06885827


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