NCT03720249

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

3.6 years

First QC Date

October 24, 2018

Last Update Submit

May 12, 2019

Conditions

Hyperhomocysteinemia

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 tested in two groups.

    12 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

supplementation of compound nutrients

EXPERIMENTAL

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.

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 betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement.

Dietary Supplement: placebo control

Interventions

supplementation of compound nutrientsDIETARY_SUPPLEMENT

Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc per day orally for 12 weeks.

Also known as: Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement
supplementation of compound nutrients
placebo controlDIETARY_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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SunYat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Lu XT, Wang YN, Mo QW, Huang BX, Wang YF, Huang ZH, Luo Y, Maierhaba W, He TT, Li SY, Huang RZ, Yang MT, Liu XZ, Liu ZY, Chen S, Fang AP, Zhang XG, Zhu HL. Effects of low-dose B vitamins plus betaine supplementation on lowering homocysteine concentrations among Chinese adults with hyperhomocysteinemia: a randomized, double-blind, controlled preliminary clinical trial. Eur J Nutr. 2023 Jun;62(4):1599-1610. doi: 10.1007/s00394-023-03087-y. Epub 2023 Jan 30.

    PMID: 36717385DERIVED

MeSH Terms

Conditions

Hyperhomocysteinemia

Interventions

Betaine

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Huilian Zhu, professor

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Huilian Zhu, professor

CONTACT

+86 20 87331811zhuhl@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
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 25, 2018

Study Start

May 20, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 14, 2019

Record last verified: 2019-05

Locations

CN(1)