HyperuricemiaPhase 4NCT03218709
The Intervention of Multi-vitamin With Minerals to Hyperuricemia
A Phase 4 study testing High-dose multi-vitamins with minerals, Low-dose multi-vitamins with minerals and Hypouricemic tablets in people with Hyperuricemia, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism in hyperuricemic adults. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- High-dose multi-vitamins with minerals, Low-dose multi-vitamins with minerals and Hypouricemic tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Apr 2018
- Phase
- Phase 4
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Under the dietary pattern of normal intake of purine, the level of serum uric acid is higher than 420μmol/L for male or 360μmol/L for female (not be detected twice at the same day).
Who cannot join
- Gouty arthritis, tophus or gouty nephropathy.
- Complications including diabetes, cardiovascular diseases (angina, myocardial infarction) and so on.
- Taken hypouricemic medicine in the last week before intervention, including allopurinol, benzbromarone, probenecid and so on.
- Had an operation in the past year.
- Malnutrition or severe obesity, BMI<18.5kg/m2 or >30.0 kg/m2.
- Mental diseases, tumor, hepatic cirrhosis or other diseases that may interfere with the intervention.
- Alcohol abuse (>80g/d)
Trial locations and contacts
1 site in 1 country.
Yi Guo, Ph.D contact
Min Xia, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, Guangdong, 510080
Min Xia, Ph.D, xiamin@mail.sysu.edu.cn
Yi Guo, Ph.D, guoyi_019@126.com
About this study
Official title: Effect of Multi-vitamins With Minerals on Uric Acid Metabolism in Subjects With Hyperuricemia: A Randomized, Double-blinded, Placebo-controlled Trail
To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism in hyperuricemic adults.
Read the detailed description
Hyperuricemia is a type of metabolic diseases which caused by purine metabolic disorder and (or) uric acid excretion disorder. Uric acid is produced by cell metabolism and food purine metabolism as the end-point product. Excess alcohol and purine-rich food intake together with abnormal function of purine metabolic key enzyme are the main causes leading increasing serum level of uric acid. It has been a focus in nutritional area that a safer approach of preventing hyperuricemia by adjustment of nutritional intake. Primary studies found that proper supplement of microelements showed significant regulations in inflammation and oxidative stress induced by elevating level of uric acid. Therefore, this study will be conducted to test whether the supplement of multi-vitamins with minerals will lower the level of blood uric acid and improve the imbalance of microelement metabolism or not. The investigators will recruit 200 subjects of study who would be divided into four groups and accept intervention of high-dose multi-vitamins with minerals, low-dose multi-vitamins with minerals, hypouricemic tablets and placebo, respectively. After intervention of 3 or 6 months, serum uric acid and purine metabolism function will be detected. This study could provide references for illuminating the mechanism in purine metabolism and nutritional measures to control the pathological development of hyperuricemia.
- Conditions
- Hyperuricemia
- Being tested
- High-dose multi-vitamins with minerals, Low-dose multi-vitamins with minerals, Hypouricemic tablets, Placebo
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose multi-vitamins with mineralsCombination product
The high-dose multi-vitamins with minerals contained vitaminB1 0.72mg,vitamin B20.72mg,vitamin B12 1.35μg,folic acid 0.37mg,vitamin C 0.27mg,vitamin D 5.04μg,selenium 30.5μg per pill, respectively.
Low-dose multi-vitamins with mineralsCombination product
The low-dose multi-vitamins with minerals contained vitaminB1 0.72mg,vitamin B20.72mg,vitamin B12 1.35μg,folic acid 0.20mg,vitamin C 0.50mg,vitamin D 5.04μg,selenium 30.5μg per pill, respectively.
Hypouricemic tabletsCombination product
The hypouricemic tablets contained skipjack,salvia and rosemary extract.
PlaceboCombination product
The placebo tablets contained maltodextrin and tartrazine.
| Study group | Role | What they receive |
|---|---|---|
| High-dose multi-vitamins with minerals | Experimental | Generic name: High-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months Receives: Combination Product: High-dose multi-vitamins with minerals |
| Low-dose multi-vitamins with minerals | Experimental | Generic name: Low-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months Receives: Combination Product: Low-dose multi-vitamins with minerals |
| Hypouricemic tablets | Active comparator | Generic name: Hypouricemic tablets Dosage form: Capsule Frequency: Six pills daily for 3 months Receives: Combination Product: Hypouricemic tablets |
| Placebo | Placebo comparator | Generic name: Placebo Dosage form: Capsule Frequency: Two pills daily for 6 months Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid
Level of uric acid was described in μmol/L
Measured: 1 year
Secondary outcomes (9)
Serum IL-1
Inflammation condition，serum IL-1 was described in ng/l.
Measured: 1.5 years
Serum IL-6
Inflammation condition, level of IL-6 was described in ng/l
Measured: 1.5 years
Serum IL-10
Inflammation condition, level of IL-10 was described in ng/l
Measured: 1.5 years
Serum TNF-α
Inflammation condition, level of TNF-α was described in ng/l
Measured: 1.5 years
Serum CRP
Inflammation condition, level of CRP was described in mg/l
Measured: 1.5 years
Serum c-peptide
Pancreas islets function, c-peptide was described in nmol/L.
Measured: 1.5 years
Serum xanthine oxidase(XOD) activity
Purine metabolism function, XOD activity was described in in U/ml.
Measured: 1.5 years
Serum phosphoribosyl pyrophosphate(PRPP)
Purine metabolism function, PRPP level was described in μmol/g Hb.
Measured: 1.5 years
Serum Glutamine(Glu)
Purine metabolism function, Glu level was described in μmol/L.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Li, Sun Yat-sen University
- Investigators
- Min Xia, Ph.D, Principal investigator, Department of Nutrition,School of Public Health,Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218709
- Sponsor's protocol ID
- ZXYZM-6
- Status last verified
- Jul 2017
- First submitted
- 22 Mar 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not share participants data
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multi-vitamins With Minerals on Uric Acid Metabolism in Subjects With Hyperuricemia: A Randomized, Double-blinded, Placebo-controlled Trail
- ClinicalTrials.gov ID
- NCT03218709
- Acronym / sponsor ID
- ZXYZM-6
- Conditions
- Hyperuricemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 14 Jul 2017 (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.
To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism in hyperuricemic adults.
Detailed description
Hyperuricemia is a type of metabolic diseases which caused by purine metabolic disorder and (or) uric acid excretion disorder. Uric acid is produced by cell metabolism and food purine metabolism as the end-point product. Excess alcohol and purine-rich food intake together with abnormal function of purine metabolic key enzyme are the main causes leading increasing serum level of uric acid. It has been a focus in nutritional area that a safer approach of preventing hyperuricemia by adjustment of nutritional intake. Primary studies found that proper supplement of microelements showed significant regulations in inflammation and oxidative stress induced by elevating level of uric acid. Therefore, this study will be conducted to test whether the supplement of multi-vitamins with minerals will lower the level of blood uric acid and improve the imbalance of microelement metabolism or not. The investigators will recruit 200 subjects of study who would be divided into four groups and accept intervention of high-dose multi-vitamins with minerals, low-dose multi-vitamins with minerals, hypouricemic tablets and placebo, respectively. After intervention of 3 or 6 months, serum uric acid and purine metabolism function will be detected. This study could provide references for illuminating the mechanism in purine metabolism and nutritional measures to control the pathological development of hyperuricemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-dose multi-vitamins with minerals | Experimental | Combination Product: High-dose multi-vitamins with mineralsGeneric name: High-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months |
| Low-dose multi-vitamins with minerals | Experimental | Combination Product: Low-dose multi-vitamins with mineralsGeneric name: Low-dose multi-vitamins with minerals tablets Dosage form: Capsule Frequency: Two pills daily for 6 months |
| Hypouricemic tablets | Active comparator | Combination Product: Hypouricemic tabletsGeneric name: Hypouricemic tablets Dosage form: Capsule Frequency: Six pills daily for 3 months |
| Placebo | Placebo comparator | Combination Product: PlaceboGeneric name: Placebo Dosage form: Capsule Frequency: Two pills daily for 6 months |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Under the dietary pattern of normal intake of purine, the level of serum uric acid is higher than 420μmol/L for male or 360μmol/L for female (not be detected twice at the same day).
Key exclusion criteria (7 listed)
- Gouty arthritis, tophus or gouty nephropathy.
- Complications including diabetes, cardiovascular diseases (angina, myocardial infarction) and so on.
- Taken hypouricemic medicine in the last week before intervention, including allopurinol, benzbromarone, probenecid and so on.
- Had an operation in the past year.
- Malnutrition or severe obesity, BMI<18.5kg/m2 or >30.0 kg/m2.
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 |
|---|---|---|
| High-dose multi-vitamins with mineralsThe high-dose multi-vitamins with minerals contained vitaminB1 0.72mg,vitamin B20.72mg,vitamin B12 1.35μg,folic acid 0.37mg,vitamin C 0.27mg,vitamin D 5.04μg,selenium 30.5μg per pill, respectively. | Combination product | High-dose multi-vitamins with minerals |
| Low-dose multi-vitamins with mineralsThe low-dose multi-vitamins with minerals contained vitaminB1 0.72mg,vitamin B20.72mg,vitamin B12 1.35μg,folic acid 0.20mg,vitamin C 0.50mg,vitamin D 5.04μg,selenium 30.5μg per pill, respectively. | Combination product | Low-dose multi-vitamins with minerals |
| Hypouricemic tabletsThe hypouricemic tablets contained skipjack,salvia and rosemary extract. | Combination product | Hypouricemic tablets |
| PlaceboThe placebo tablets contained maltodextrin and tartrazine. | Combination product | Placebo |
Primary outcome
Serum uric acid
Time frame: 1 year
Level of uric acid was described in μmol/L
9 secondary outcomes
Serum IL-1
Time frame: 1.5 years
Serum IL-6
Time frame: 1.5 years
Serum IL-10
Time frame: 1.5 years
Serum TNF-α
Time frame: 1.5 years
Serum CRP
Time frame: 1.5 years
Serum c-peptide
Time frame: 1.5 years
Serum xanthine oxidase(XOD) activity
Time frame: 1.5 years
Serum phosphoribosyl pyrophosphate(PRPP)
Time frame: 1.5 years
Serum Glutamine(Glu)
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Individual participant dataSharing planned: No. Do not share participants data
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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.
Yi Guo, Ph.D contact
Min Xia, Ph.D contact
Min Xia, Ph.D principal investigator
Department of Nutrition,School of Public Health,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 Phase 4 study testing High-dose multi-vitamins with minerals, Low-dose multi-vitamins with minerals and Hypouricemic tablets in people with Hyperuricemia, run by Sun Yat-sen University 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 1 inclusion and 7 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 Jul 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yi Guo, Ph.D (guoyi_019@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum uric acid (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2017.