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Investigators seek to quantify the impact of vitamin C on patient outcomes, including serum urate level, gout-related symptoms, and obesity (measured by BMI) in both healthy Hmong adults and in Hmong patients with hyperuricemia (HU) and/or gout; identify associations between individuals' taxonomic and functional patterns of gut microbiota and its impact on the serum urate-lowering effect of vitamin C; compare taxonomic and functional patterns of gut microbiota between people with HU and/or gout and people without HU and gout; and identify associations between individuals' taxonomic and functional patterns of gut microbiota and self-reported acute gout trigger foods.
Gout, caused by chronic elevation of serum urate (SU), is the most common form of inflammatory arthritis worldwide. About 3.9% of adults in the U.S. suffer from gout and prevalence is even higher in certain ethnicities. Factors that may influence SU include patients' characteristics (gender, weight, renal function, etc.), genetics, and diet. Foods and beverages that have shown positive association with HU and gout are alcohol (particularly beer), purine-rich foods, red meat, seafood, and sugar-sweetened drinks, while inverse association has been found with dairy intake such as skimmed milk and low-calorie yoghurt, coffee and vitamin C. The gut microbiota composition and function have been linked to common chronic human disorders, such as obesity, diabetes, non-alcoholic fatty liver disease, and rheumatoid arthritis. Intestinal microbiota of gout patients were also found highly distinct from healthy individuals in both organismal and functional structures from a small study conducted in China. Strategies to use personal microbiome features to predict glucose response to specific food have been proposed. However, little is known about the impact of microbiota on food and urate-lowering therapy (ULT). The translational significance of a microbiota-guided approach to select appropriate foods and medications that could prevent the elevation of SU for individuals with gout or at high risk for gout is significant. The Hmong are a unique Asian sub-population. Hmong men exhibit a 2-fold higher prevalence of gout, manifesting it earlier in life and experiencing up to 5-fold increased risk of gout-associated complications, compared to non-Hmong in the US. This could lead to higher rates of cardiometabolic diseases (e.g. hypertension, renal disease, type 2 diabetes [T2DM]), which significantly impact morbidity, mortality and healthcare costs. Accordingly, the investigators seek to quantify the impact of vitamin C on patient outcomes, including serum urate level, gout-related symptoms, and obesity (measured by BMI) in both healthy Hmong adults and in Hmong patients with hyperuricemia (HU) and/or gout; identify associations between individuals' taxonomic and functional patterns of gut microbiota and its impact on the serum urate-lowering effect of vitamin C; compare taxonomic and functional patterns of gut microbiota between people with HU and/or gout and people without HU and gout; and identify associations between individuals' taxonomic and functional patterns of gut microbiota and self-reported acute gout trigger foods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with hyperuricemia (HU) or gout without urate-lowering therapy (ULT) | Experimental | Participants with HU or gout who are not treated with ULT will take 500 mg of vitamin C twice daily for 8 weeks. |
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| People with hyperuricemia (HU) or gout with urate-lowering therapy (ULT) | Experimental | Participants with HU or gout who are treated with ULT will take 500 mg of vitamin C twice daily for 8 weeks. |
|
| People without hyperuricemia (HU) or gout without urate-lowering therapy (ULT) | Active Comparator | Participants without HU or gout who are not treated with ULT will take 500 mg of vitamin C twice daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Dietary Supplement | Vitamin C is a commercially available over-the-counter food supplement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum urate | Serum urate levels (mg/dL) will be measured from baseline to end, and the absolute difference will be reported. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gout Assessment Questionnaire 2.0 score | The Gout Assessment Questionnaire 2.0 (GAQ2.0) contains 25 items covering the following domains: gout overall concern, medication side effects, perception of unmet needs, wellbeing during acute gout attack, and concerns during gout attack. Items are rated on a 5-point likert scale. Total scores range from 25 to 125 with higher scores indicating more gout symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
Allergy or sensitivity to vitamin C
Diagnosis/history of:
Pregnant or breastfeeding persons
Current use of:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Straka, PharmD, FCCP | Univeristy of Minnesota Department of Experimental and Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36724193 | Derived | Wen YF, Culhane-Pera KA, Pergament SL, Moua Y, Vue B, Yang T, Lo M, Sun B, Knights D, Straka RJ. Hmong microbiome ANd Gout, Obesity, Vitamin C (HMANGO-C): A phase II clinical study protocol. PLoS One. 2023 Feb 1;18(2):e0279830. doi: 10.1371/journal.pone.0279830. eCollection 2023. |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 8 weeks |
| Change in body mass index (BMI) | Change in body mass index (BMI) from baseline to end. BMI is calculated as body weight (in kg) divided by height (in cm) squared. BMI is reported in kg/m^2, and the change will be reported as an absolute value. | 8 weeks |
| Change in Swollen Joint Count (44 Joints) | Change in gout-related symptoms will be measured from baseline to end using the Swollen Joint Count (44 Joints) post-administration of vitamin C. Scores range from 0-44 with higher scores indicating more swollen joints. | 8 weeks |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |