The Intervention of Multi-vitamin With Minerals to Hyperuricemia

Hyperuricemia Clinical Trial

Official title:

Effect of Multi-vitamins With Minerals on Uric Acid Metabolism in Subjects With Hyperuricemia: A Randomized, Double-blinded, Placebo-controlled Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218709
• Other study ID #: ZXYZM-6
• Status: Recruiting
• Phase: Phase 4
• First received: March 22, 2017
• Last updated: July 13, 2017
• Start date: January 2017
• Est. completion date: April 2018

Study information

• Verified date: July 2017
• Source: Sun Yat-sen University
• Contact: Yi Guo, Ph.D
• Email: guoyi_019[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism in hyperuricemic adults.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Combination Product:
• High-dose multi-vitamins with minerals
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 minerals
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 tablets
The hypouricemic tablets contained skipjack,salvia and rosemary extract.
• Placebo
The placebo tablets contained maltodextrin and tartrazine.

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum uric acid	Level of uric acid was described in µmol/L	1 year
Secondary	Serum IL-1	Inflammation condition,serum IL-1 was described in ng/l.	1.5 years
Secondary	Serum IL-6	Inflammation condition, level of IL-6 was described in ng/l	1.5 years
Secondary	Serum IL-10	Inflammation condition, level of IL-10 was described in ng/l	1.5 years
Secondary	Serum TNF-a	Inflammation condition, level of TNF-a was described in ng/l	1.5 years
Secondary	Serum CRP	Inflammation condition, level of CRP was described in mg/l	1.5 years
Secondary	Serum c-peptide	Pancreas islets function, c-peptide was described in nmol/L.	1.5 years
Secondary	Serum xanthine oxidase(XOD) activity	Purine metabolism function, XOD activity was described in in U/ml.	1.5 years
Secondary	Serum phosphoribosyl pyrophosphate(PRPP)	Purine metabolism function, PRPP level was described in µmol/g Hb.	1.5 years
Secondary	Serum Glutamine(Glu)	Purine metabolism function, Glu level was described in µmol/L.	1.5 years