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:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00110604
Eligibility Criteria:
Inclusion Criteria:
* 50-70 years
* Men and post-menopausal women
* Women with a surgically removed uterus were required to be \>=55 years
Exclusion Criteria:
* Plasma total homocysteine \<13 or \>26 umol/L
* Serum vitamin B12 \<200 pmol/L
* Self-reported current use of drugs which affect folate metabolism
* Self-reported current use of drugs believed to influence intima-media thickening, i.e., lipid-lowering drugs, hormone replacement therapy
* Self-reported medical diagnosis of renal, intestinal, thyroid disease
* Self-reported medical diagnosis of current cancer
* Self-reported current use of supplements containing B vitamins
* Self-reported inability or unwillingness to fast for 12 hours
* \<80% compliance using placebo pills during a 6-week run-in period
* Not giving written informed consent
* Participation in other research studies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT00110604
Study Brief:
Protocol Section:
NCT00110604