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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06363565
Other study ID # MN-2022-11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Sun Yat-sen University
Contact Huilian Zhu, professor
Phone +86 20 87331811
Email zhuhl@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
supplementation of compound nutrients
Folic acid, vitamin B6, vitamin B12, and betaine per day orally for 12 weeks.
placebo control
The placebo is an excipient and the color, flavor, shape, taste, and weight are same with the tablet of supplement.

Locations

Country Name City State
China SunYat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT00172250 - The Study of Relationship of Plasma Concentrations of Folic Acid, Vitamin B and Homocysteine With Carotid Atherosclerosis and Endothelium-Dependent Vasodilatation of Geriatric and Young Patients in the Ambulatory Care Department of NTUH N/A
Completed NCT02575092 - The Relationship Between HHcy and Contrast-induced Nephropathy in Hypertensive Patients After Coronary Artery Diagnosis and Treatment Phase 2/Phase 3
Enrolling by invitation NCT03595163 - Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children N/A