Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07312435
Eligibility Criteria:
Inclusion Criteria:
* Age \> 65 years
* A low baseline B-vitamin status as assessed by plasma tHcy \> 11 μmol/L
* Normal MMSE score (\>25)
Exclusion Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07312435
Study Brief:
Protocol Section:
NCT07312435