Supplementing nutrients to lower homocysteine levels in Chinese adults
Study on the Effect of Compound Nutrients on Reducing Homocysteine -- A 3-month Double-blind Randomized Controlled Trial
This study is testing if a mix of vitamins and nutrients can help lower high homocysteine levels in Chinese adults aged 18 to 65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06363565 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a combination of nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, on reducing plasma homocysteine levels in Chinese adults with elevated homocysteine. Participants aged 18 to 65 with plasma homocysteine levels above 10 μmol/L will receive either the nutrient supplementation or a placebo. The study will assess the changes in plasma homocysteine levels after the intervention period. The goal is to determine if these nutrients can effectively lower homocysteine concentrations.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults aged 18 to 65 with plasma homocysteine levels between 10 and 100 μmol/L.
Not a fit: Patients who are pregnant, lactating, or have severe diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a simple nutritional intervention to help lower homocysteine levels, potentially reducing the risk of cardiovascular diseases.
How similar studies have performed: Previous studies have shown that nutrient supplementation can effectively lower homocysteine levels, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 - 65 years; 2. Concentration of plasma homocysteine is between 10 and 100 μmol/L; 3. Free from any supplements or drugs that may decrease plasma homocysteine concentration for at least 1 month prior to the beginning of study; 4. Willing to participate in the study and sign informed consent. Exclusion Criteria: 1. Pregnant or lactating women; 2. Allergic physique or allergic to our compound nutrients tablets; 3. Complicated with severe diseases; 4. Unable to conduct study procedures; 5. Participating in any other intervention studies.
Where this trial is running
Guangzhou, Guangdong
- SunYat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Huilian Zhu, professor
- Email: zhuhl@mail.sysu.edu.cn
- Phone: +86 20 87331811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.