NCT06363565
Recruiting
Not Applicable
Study on the Effect of Compound Nutrients on Reducing Homocysteine -- A 3-month Double-blind Randomized Controlled Trial
Sun Yat-sen University1 site in 1 country220 target enrollmentJune 1, 2023
ConditionsHomocysteine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Homocysteine
- Sponsor
- Sun Yat-sen University
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- levels of homocysteine
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to determine whether supplementation of compound nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, will decrease the level of plasma homocysteine in Chinese adults with homocysteine levels above 10 μmol/L.
Investigators
Huilian Zhu
Sun Yat-sen University
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Aged 18 - 65 years;
- •Concentration of plasma homocysteine is between 10 and 100 μmol/L;
- •Free from any supplements or drugs that may decrease plasma homocysteine concentration for at least 1 month prior to the beginning of study;
- •Willing to participate in the study and sign informed consent.
Exclusion Criteria
- •Pregnant or lactating women;
- •Allergic physique or allergic to our compound nutrients tablets;
- •Complicated with severe diseases;
- •Unable to conduct study procedures;
- •Participating in any other intervention studies.
Outcomes
Primary Outcomes
levels of homocysteine
Time Frame: 12 weeks
At baseline, 4 weeks, and 12 weeks, blood samples will be drawn and levels of homocysteine will be determined in the two groups.
Study Sites (1)
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