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

NCT04938024 | Completed

• 1 other identifier: PHARM-2020-29354
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperuricemia; Gout

Outcome Measures

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.

  8 weeks

Secondary Outcomes (3)

• Change in Gout Assessment Questionnaire 2.0 score

  8 weeks

• Change in body mass index (BMI)

  8 weeks

• Change in Swollen Joint Count (44 Joints)

  8 weeks

Study Arms (3)

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.

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.

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.

Dietary Supplement: Vitamin C

Interventions

Vitamin C DIETARY_SUPPLEMENT

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

Also known as: L-ascorbic acid

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 36724193 DERIVED

MeSH Terms

Conditions

Hyperuricemia; Gout

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Robert J Straka, PharmD, FCCP

  Univeristy of Minnesota Department of Experimental and Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 24, 2021
• Study Start: March 28, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (1)