HyperhomocysteinemiaNCT03720249
Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia
A study testing supplementation of compound nutrients in people with Hyperhomocysteinemia, run by Huilian Zhu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperhomocysteinemia
- What is being tested?
- supplementation of compound nutrients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial
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.
- Conditions
- Hyperhomocysteinemia
- Being tested
- supplementation of compound nutrients, placebo control
- Medical subject headings
- Hyperhomocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementation of compound nutrientsDietary supplement
Also called Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement
Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc per day orally for 12 weeks.
placebo controlDietary supplement
The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of supplement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine will be tested in two groups.
Measured: 12 weeks
levels of s-adenosyl-methionine and s-adenosyl-homocysteine
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of s-adenosyl-methionine (SAM) and s-adenosyl-homocysteine (SAH) will be tested in two groups.
Measured: 12 weeks
anthropomorphic measurements and blood biochemical markers
Anthropomorphic measurements such as height, weight, waist circumference, hip circumference, vascular endothelial function, cardiopulmonary function, body composition and so on, and blood biochemical markers such as overnight fasting serum total cholesterol (TC), triglyceride (TG), LDL cholesterol (LDLc), HDL cholesterol (HDLc), fasting blood glucose and so on will be measured.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start20 May 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperhomocysteinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huilian Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huilian Zhu, Sun Yat-sen University
- Investigators
- Huilian Zhu, professor, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720249
- Sponsor's protocol ID
- MN-2018-10
- Status last verified
- May 2019
- First submitted
- 24 Oct 2018
- Last updated
- 14 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36717385
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial
- ClinicalTrials.gov ID
- NCT03720249
- Acronym / sponsor ID
- MN-2018-10
- Conditions
- Hyperhomocysteinemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huilian ZhuUniversity, hospital or other
- Study start
- 20 May 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supplementation of compound nutrients | Experimental | Dietary Supplement: supplementation of compound nutrientsBetaine、(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. |
| placebo control | Placebo comparator | Dietary Supplement: placebo controlThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplementation of compound nutrientsAlso: Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplementBetaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc per day orally for 12 weeks. | Dietary supplement | supplementation of compound nutrients |
| placebo controlThe placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of supplement. | Dietary supplement | placebo control |
Primary outcome
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.
3 secondary outcomes
levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine
Time frame: 12 weeks
levels of s-adenosyl-methionine and s-adenosyl-homocysteine
Time frame: 12 weeks
anthropomorphic measurements and blood biochemical markers
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Derived from this study: PubMed 36717385Lu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huilian Zhu, professor study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation of compound nutrients in people with Hyperhomocysteinemia, run by Huilian Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huilian Zhu, professor (+86 20 87331811, zhuhl@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of homocysteine (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.