CompletedPhase 3

Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly

China390 participantsStarted 2007-07

Plain-language summary

The purpose of this study is to evaluate whether low dose complex B-vitamins (folic acid,vitamin B6 and vitamin B12) can lower the risk of developing hyperhomocysteinemia in an apparently healthy population with low folate/B12 and high Hcy status.

Who can participate

Age range

60 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female residents living in the field site for at least 12 months * Aged 60-74 years Exclusion Criteria: * History of chronic disease and taking medications for treatment such as CVD, COPD, cancer, severe renal and liver disease, diabetes. * Use of multivitamins, and individual vitamins such as folic acid, B12, or B6 in the last 6 months. * Taking medications known to interfere with folate metabolism, including methotrexate, tamoxifen, L-DOPA, niacin, phenytoin, bile acid sequestrants; anticonvulsant medications (such as dilantin, phenytoin, and primidone), Metformin, Sulfasalazine. * Conditions that prevent participation or compliance such as Downs syndrome, mental problems, or severe cognitive impairment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score

Timeframe: 6,12 and 18 months

Trial details

NCT IDNCT00755664

SponsorPeking University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-09

View on ClinicalTrials.gov More Hyperhomocysteinemia trials

Who can participate

Age range

60 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.