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

Not Applicable

Recruiting

• Conditions: Homocysteine
• Interventions: Dietary Supplement: supplementation of compound nutrients; Dietary Supplement: placebo control

• Registration Number: NCT06363565
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supplementation of compound nutrients	supplementation of compound nutrients	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.
placebo control	placebo control	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

SunYat-sen University; 🇨🇳 Guangzhou, Guangdong, China