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

Huilian Zhu

Status: Unknown

Conditions: Hyperhomocysteinemia

Treatments: Dietary Supplement: supplementation of compound nutrients; Dietary Supplement: placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT03720249

MN-2018-10

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

supplementation of compound nutrients

Experimental group

Description:

Betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc are provided as a 800mg tablet. And the tablet is orally taken once a day, four tablets at a time for 12 weeks.

Treatment:

Dietary Supplement: supplementation of compound nutrients

placebo control

Placebo Comparator group

Description:

The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement.

Treatment:

Dietary Supplement: placebo control