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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Homocysteine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

supplementation of compound nutrients

Intervention Type DIETARY_SUPPLEMENT

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 folic acid, vitamin B6, vitamin B12, and betaine supplement.

Group Type PLACEBO_COMPARATOR

placebo control

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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supplementation of compound nutrients

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

Intervention Type DIETARY_SUPPLEMENT

placebo control

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Folic acid, vitamin B6, vitamin B12, and betaine supplement

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes