Homocysteine
Conditions
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.
Interventions
DIETARY_SUPPLEMENTsupplementation of compound nutrients
Folic acid, vitamin B6, vitamin B12, and betaine per day orally for 12 weeks.
DIETARY_SUPPLEMENTplacebo control
The placebo is an excipient and the color, flavor, shape, taste, and weight are same with the tablet of supplement.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| levels of homocysteine | 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. |
Countries
China
Contacts
Primary ContactHuilian Zhu, professor
Outcome results
None listed