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

Sun Yat-sen University220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

220

Conditions

Homocysteine

Interventions

supplementation of compound nutrientsDIETARY_SUPPLEMENT

Folic acid, vitamin B6, vitamin B12, and betaine per day orally for 12 weeks.

placebo controlDIETARY_SUPPLEMENT

The placebo is an excipient and the color, flavor, shape, taste, and weight are same with the tablet of supplement.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

SunYat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

levels of homocysteine

At baseline, 4 weeks, and 12 weeks, blood samples will be drawn and levels of homocysteine will be determined in the two groups.

Time frame: 12 weeks

Central Contacts

Huilian Zhu, professor

CONTACT

+86 20 87331811 zhuhl@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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