HyperuricemiaNCT04938024
Hmong Microbiome ANd Gout, Obesity, Vitamin C (HMANGO-C)
A study testing Vitamin C in people with Hyperuricemia and Gout, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, Gout
- What is being tested?
- Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2021to 30 Aug 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
- Conditions
- Hyperuricemia, Gout
- Being tested
- Vitamin C
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Also called L-ascorbic acid
Vitamin C is a commercially available over-the-counter food supplement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Vitamin C |
| 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. Receives: Dietary Supplement: Vitamin C |
| 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. Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum urate
Serum urate levels (mg/dL) will be measured from baseline to end, and the absolute difference will be reported.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start28 Mar 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
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 HyperuricemiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Straka, PharmD, FCCP, Principal investigator, Univeristy of Minnesota Department of Experimental and Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938024
- Sponsor's protocol ID
- PHARM-2020-29354
- Status last verified
- Sep 2023
- First submitted
- 14 Jun 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36724193
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hmong Microbiome ANd Gout, Obesity, Vitamin C (HMANGO-C)
- ClinicalTrials.gov ID
- NCT04938024
- Acronym / sponsor ID
- PHARM-2020-29354
- Conditions
- Hyperuricemia, Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 24 Jun 2021 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People with hyperuricemia (HU) or gout without urate-lowering therapy (ULT) | Experimental | Dietary Supplement: Vitamin CParticipants with HU or gout who are not treated with ULT will take 500 mg of vitamin C twice daily for 8 weeks. |
| People with hyperuricemia (HU) or gout with urate-lowering therapy (ULT) | Experimental | Dietary Supplement: Vitamin CParticipants 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 | Dietary Supplement: Vitamin CParticipants without HU or gout who are not treated with ULT will take 500 mg of vitamin C twice daily for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (14 listed)
- Allergy or sensitivity to vitamin C
- Diagnosis/history of:
- Pregnant or breastfeeding persons
- Current use of:
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 |
|---|---|---|
| Vitamin CAlso: L-ascorbic acidVitamin C is a commercially available over-the-counter food supplement. | Dietary supplement | People with hyperuricemia (HU) or gout with urate-lowering therapy (ULT), People with hyperuricemia (HU) or gout without urate-lowering therapy (ULT), People without hyperuricemia (HU) or gout without urate-lowering therapy (ULT) |
Primary outcome
Change in serum urate
Time frame: 8 weeks
Serum urate levels (mg/dL) will be measured from baseline to end, and the absolute difference will be reported.
3 secondary outcomes
Change in Gout Assessment Questionnaire 2.0 score
Time frame: 8 weeks
Change in body mass index (BMI)
Time frame: 8 weeks
Change in Swollen Joint Count (44 Joints)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 36724193Wen 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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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.
Robert J Straka, PharmD, FCCP principal investigator
Univeristy of Minnesota Department of Experimental and Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Hyperuricemia and Gout, run by University of Minnesota at 1 site in United States.
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 2 inclusion and 14 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: finished, as of the sponsor's last update on 7 Sep 2023. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum urate (time frame: 8 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 NCT04938024, 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 7 Sep 2023.