Open-angle GlaucomaIVMGSNCT06885827
Vitamin Mix (B6, B9, B12, And Choline) For Glaucoma Patients
A study testing Vitamin B-mix in people with Open-angle Glaucoma and Pseudoexfoliation Glaucoma, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Pseudoexfoliation Glaucoma
- What is being tested?
- Vitamin B-mix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSweden
- Study dates
- 31 Mar 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
James Tribble, Associate Professor contact
Sweden2 sites, 2 recruiting
- Recruiting
St Eriks Ögonsjukhus
Stockholm, Stockholm County, 11251
Navid Golpour, Medical doctor, +46737085148, navid.golpour@ki.se
James Tribble, BSc, PhD.
- Not yet recruiting
Karolinska institutet, The Division of Eye and vision.
Stockholm, Stockholm County, 14186
Rune Brautaset, Professor of Optometry
About this study
Official title: Interventional Vitamin Mix Glaucoma Study (IVMGS) - A Prospective, Randomized, Two-Arm, Single-Center Study Protocol in Existing Glaucoma Patients.
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.
Read more
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
- Open-angle Glaucoma, Pseudoexfoliation Glaucoma
- Being tested
- Vitamin B-mix, Standard Care
- Keywords
- methyl donor supplementation, glaucoma, neuroprotection, randomized clinical trial, open-label, B6, B9, choline, visual field, optical coherence tomography, electroretinogram
- Medical subject headings
- Glaucoma, Open-Angle, Exfoliation Syndrome, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B-mixDietary 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.
Standard CareOther
Usual glaucoma management (e.g., monitoring and/or IOP-lowering treatments) without additional supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Participants in this arm receive both the Vitamin B-mix supplement and standard glaucoma care. Receives: Dietary Supplement: Vitamin B-mix |
| Controls | Active comparator | Participants in this arm receive standard glaucoma care only. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in photopic negative response (PhNR) on electroretinography (ERG)
The primary outcome is the change in retinal function as measured by the PhNR on ERG over a 12-month period.
Measured: Baseline, third month and twelfth month.
Secondary outcomes (7)
Changes to retinal structure
Measurement of retinal nerve fiber layer (RNFL) and ganglion cell layer-inner plexiform layer (GCL-IPL) thickness via OCT.
Measured: Baseline, third month and twelfth month.
Change in Visual Field Index (VFI)
Changes in Visual Field Index (VFI) assessed by automated perimetry. Unit of Measure: Percentage (%).
Measured: Baseline, third month, and twelfth month.
Blood biomarkers
Analysis of blood metabolomic profiles and global DNA methylation levels to evaluate systemic effects of the intervention.
Measured: Baseline, third month and twelfth month.
Intraocular Pressure (IOP)
Measured using ICare tonometer.
Measured: From baseline to twelfth months.
Change in Best Corrected Visual Acuity (BCVA)
Measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
Minimum Value: 0 (worst visual acuity). Maximum Value: 100 (best visual acuity) Interpretation: Higher scores indicate better visual acuity.
Measured: From baseline to twelfth months.
Change in Mean Deviation (MD)
Changes in Mean Deviation (MD) assessed by automated perimetry. Unit of Measure: Decibels (dB).
Measured: Baseline, third month, and twelfth month.
Change in Pattern Standard Deviation (PSD)
Changes in Pattern Standard Deviation (PSD) assessed by automated perimetry. Unit of Measure: Decibels (dB)
Measured: Baseline, third month, and twelfth month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start31 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- St. Erik Eye Hospital
- Responsible party
- Principal investigator, Rune Brautaset, Karolinska Institutet
- Investigators
- Rune Brautaset, Professor of Optometry, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885827
- Sponsor's protocol ID
- 2023-06239-01
- Other IDs
- 2023
- Acronym
- IVMGS
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We aim to share pseudonymized individual participant data that underlie results in a publication in accordance with institutional regulations.
Publications
Golpour N, Hui F, Nilsson M, Svensson J, Brautaset RL, Tribble JR, Williams PA. Interventional Vitamin Mix Glaucoma Study (IVMGS): study protocol for a prospective, randomized, two-arm, single-center trial in existing glaucoma patients. Trials. 2025 Oct 13;26(1):403. doi: 10.1186/s13063-025-09168-z.
PubMed 41084053
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Vitamin Mix Glaucoma Study (IVMGS) - A Prospective, Randomized, Two-Arm, Single-Center Study Protocol in Existing Glaucoma Patients.
- ClinicalTrials.gov ID
- NCT06885827
- Acronym / sponsor ID
- IVMGS / 2023-06239-01
- Conditions
- Open-angle Glaucoma, Pseudoexfoliation Glaucoma
- Keywords
- methyl donor supplementation, glaucoma, neuroprotection, randomized clinical trial, open-label, B6, B9, choline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- St. Erik Eye Hospital
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Vitamin B-mixParticipants in this arm receive both the Vitamin B-mix supplement and standard glaucoma care. |
| Controls | Active comparator | Other: Standard CareParticipants in this arm receive standard glaucoma care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B-mixDaily 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. | Dietary supplement | Intervention |
| Standard CareUsual glaucoma management (e.g., monitoring and/or IOP-lowering treatments) without additional supplementation. | Other | Controls |
Primary outcome
Change in photopic negative response (PhNR) on electroretinography (ERG)
Time frame: Baseline, third month and twelfth month.
The primary outcome is the change in retinal function as measured by the PhNR on ERG over a 12-month period.
7 secondary outcomes
Changes to retinal structure
Time frame: Baseline, third month and twelfth month.
Change in Visual Field Index (VFI)
Time frame: Baseline, third month, and twelfth month.
Blood biomarkers
Time frame: Baseline, third month and twelfth month.
Intraocular Pressure (IOP)
Time frame: From baseline to twelfth months.
Change in Best Corrected Visual Acuity (BCVA)
Time frame: From baseline to twelfth months.
Change in Mean Deviation (MD)
Time frame: Baseline, third month, and twelfth month.
Change in Pattern Standard Deviation (PSD)
Time frame: Baseline, third month, and twelfth month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 41084053Golpour N, Hui F, Nilsson M, Svensson J, Brautaset RL, Tribble JR, Williams PA. Interventional Vitamin Mix Glaucoma Study (IVMGS): study protocol for a prospective, randomized, two-arm, single-center trial in existing glaucoma patients. Trials. 2025 Oct 13;26(1):403. doi: 10.1186/s13063-025-09168-z.
- Individual participant dataSharing planned: Undecided. We aim to share pseudonymized individual participant data that underlie results in a publication in accordance with institutional regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Tribble, Associate Professor contact
Rune Brautaset, Professor of Optometry principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B-mix in people with Open-angle Glaucoma and Pseudoexfoliation Glaucoma, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Navid Golpour, Medical doctor (+46737085148, navid.golpour@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in photopic negative response (PhNR) on electroretinography (ERG) (time frame: Baseline, third month and twelfth month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06885827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.