NCT07312435 · RECRUITING
B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy.
This trial is testing whether a combined supplement of B-vitamins and omega-3 fatty acids can reduce a blood marker of brain cell damage called neurofilament light chain in adults over 65 with low B-vitamin levels. It is a Phase NA designation, meaning this is a straightforward randomized controlled trial focused on measuring biological effects, not a staged drug approval process. Researchers will also look at cognitive function and quality of life over three months.
You may qualify if
- Age > 65 years
- A low baseline B-vitamin status as assessed by plasma tHcy > 11 μmol/L
- Normal MMSE score (>25)
You're excluded if
- Unable to give informed consent
- Fatty fish intake > 2 times per week
- daily omega-3 supplementation
- daily B-vitamin supplementation
- history of B12-injections
- Serum creatinine > 90 μmol/L for women and > 105 μmol/L for men (above reference values)
- aspirin use
- renal disease
- active cancer
- Participants can be included if they accept to not take omega-3 supplementation or B-vitamin supplements during the study. They should stop using it and wait 12 weeks before they are invited to a screening visit.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-12-31