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

NCT06363565 | Recruiting

• 1 other identifier: MN-2022-11
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Homocysteine

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (2)

supplementation of compound nutrients

EXPERIMENTAL

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.

Dietary Supplement: supplementation of compound nutrients

placebo control

PLACEBO COMPARATOR

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.

Dietary Supplement: placebo control

Interventions

supplementation of compound nutrients DIETARY_SUPPLEMENT

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

Also known as: Folic acid, vitamin B6, vitamin B12, and betaine supplement

supplementation of compound nutrients

placebo control DIETARY_SUPPLEMENT

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

placebo control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SunYat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Folic Acid; Vitamin B 6; Vitamin B 12

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Huilian Zhu, professor

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Huilian Zhu, professor

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)