Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults

Sun Yat-sen University

Status: Enrolling

Conditions: Homocysteine

Treatments: Dietary Supplement: supplementation of compound nutrients; Dietary Supplement: placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT06363565

MN-2022-11

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

supplementation of compound nutrients

Experimental group

Description:

Folic acid, vitamin B6, vitamin B12, and betaine are provided as a 1.0g tablet. the tablet is orally taken twice a day, two tablets at a time 12 weeks.

Treatment:

Dietary Supplement: supplementation of compound nutrients

placebo control

Placebo Comparator group

Description:

The placebo is an excipient and the color, flavor, shape, taste, and weight are same with the tablet of folic acid, vitamin B6, vitamin B12, and betaine supplement.

Treatment:

Dietary Supplement: placebo control