Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06885827

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

Led by Karolinska Institutet · Updated on 2025-04-29

80

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

S

St. Erik Eye Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at the time of inclusion
  • Diagnosis of Primary Open-Angle Glaucoma, Normal Tension-Glaucoma, or Pseudoexfoliation Glaucoma in one or both eyes diagnosed by an ophthalmologist
  • Best corrected Snellen visual acuity of 0.3 or better in the study eye(s)
  • Two or more reliable visual field tests with less than 15% false positives
Not Eligible

You will not qualify if you...

  • Visual field damage worse than -16dB in the study eye(s)
  • Eye pressure over 35 mmHg on two occasions or a mean pressure of 30 mmHg over two occasions in the study eye(s)
  • 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 intake of multivitamins or B vitamin substances
  • Known allergy or intolerance to B vitamins
  • Previous eye surgery except uncomplicated cataract surgery
  • Pregnant or breastfeeding women
  • Women of childbearing potential not using 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

St Eriks Ögonsjukhus

Stockholm, Stockholm County, Sweden, 11251

Actively Recruiting

2

Karolinska institutet, The Division of Eye and vision.

Stockholm, Stockholm County, Sweden, 14186

Not Yet Recruiting

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Research Team

N

Navid Golpour, Medical doctor

CONTACT

J

James Tribble, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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