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CompletedNCT04938024Updated Sep 7, 2023

Hmong Microbiome ANd Gout, Obesity, Vitamin C (HMANGO-C)

An interventional study of Vitamin C in Hyperuricemia and Gout, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
135
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Hyperuricemia
  • Gout

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03

In context

Gout

232 studies on the registry are indexed under Gout; 45 are open to participants now.

This study's enrollment of 135 is above the median of 121 across 202 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Self-identified Hmong persons whose both parents are Hmong, with and without hyperuricemia (serum urate (UA) ≥ 6.8 mg/dL ) and/or gout (defined by 2020 American College of Rheumatology Guideline for the Management of Gout) are eligible for the study.
  • For those with gout, participants qualify if they have serum UA ≥ 6.8 mg/dL based on the baseline measurement or serum UA \< 6.8 mg/dL based on the baseline measurement with at least 1 episode of peripheral joint or bursal swelling, pain, or tenderness (acute gout flare) in their lifetime, (with or without urate-lowering therapy)

Exclusion criteria

Exclusion Criteria:

  • Allergy or sensitivity to vitamin C
  • Diagnosis/history of:

    • Gastrointestinal surgery including colectomy, ileectomy, and gastrectomy
    • Inflammatory bowel disease
    • Auto-immune disease
    • Type I diabetes mellitus
    • Severe kidney disease (i.e., on dialysis)
    • End-stage liver disease (i.e. cirrhosis)
    • Glucose-6-phosphate dehydrogenase deficiency, (due to increased bleeding risk in those with G6PD deficiency when receiving vitamin C)
  • Pregnant or breastfeeding persons
  • Current use of:

    • Antibiotics
    • Probiotics supplement
    • Ketogenic diet
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
135 participants (actual)

Study arms

  • Experimental
    People with hyperuricemia (HU) or gout without urate-lowering therapy (ULT)

    Participants with HU or gout who are not treated with ULT will take 500 mg of vitamin C twice daily for 8 weeks.

    Dietary Supplement: Vitamin C

  • Experimental
    People with hyperuricemia (HU) or gout with urate-lowering therapy (ULT)

    Participants with HU or gout who are treated with ULT will take 500 mg of vitamin C twice daily for 8 weeks.

    Dietary Supplement: Vitamin C

  • Active comparator
    People without hyperuricemia (HU) or gout without urate-lowering therapy (ULT)

    Participants without HU or gout who are not treated with ULT will take 500 mg of vitamin C twice daily for 8 weeks.

    Dietary Supplement: Vitamin C

Interventions

  • Dietary supplementVitamin C

    Vitamin C is a commercially available over-the-counter food supplement.

    Also known as: L-ascorbic acid

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What researchers measure

Primary outcomes

  1. Change in serum urate

    Serum urate levels (mg/dL) will be measured from baseline to end, and the absolute difference will be reported.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04938024
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jun 24, 2021
Start date
Mar 28, 2021
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023
Last update
Sep 7, 2023

Study contacts

Robert J Straka, PharmD, FCCP
principal investigator · Univeristy of Minnesota Department of Experimental and Clinical Pharmacology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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