Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial

Huilian Zhu1 site in 1 country100 target enrollmentMay 20, 2019

ConditionsHyperhomocysteinemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hyperhomocysteinemia
Sponsor: Huilian Zhu
Enrollment: 100
Locations: 1
Primary Endpoint: levels of homocysteine
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether supplementation of compound nutrients,including folic acid, vitamin B6, vitamin B12, betaine and zinc, will decrease the level of plasma homocysteine in Chinese adults with hyperhomocysteinemia.

Registry

clinicaltrials.gov

Start Date

May 20, 2019

End Date

December 31, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huilian Zhu

Responsible Party

Sponsor Investigator

Principal Investigator

Huilian Zhu

professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•People aged 18-65 years.
•The level of plasma homocysteine is 15-100μmol/L.
•Free from products which could decrease plasma homocysteine for at least one month.
•Willing to participate in the study, consume the test product and perform all measurements.

Exclusion Criteria

•pregnant or lactating women.
•severe diseases need to control.
•people who unconsciousness and can not complete questionnaire.
•long-term regular use of vitamin or mineral supplements.

Outcomes

Primary Outcomes

levels of homocysteine

Time Frame: 12 weeks

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

Secondary Outcomes

levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine(12 weeks)
levels of s-adenosyl-methionine and s-adenosyl-homocysteine(12 weeks)
anthropomorphic measurements and blood biochemical markers(12 weeks)