NCT05720702CompletedEarly phase 1
A Feasibility Trial of OCM Supplements for the Treatment of NAFLD
A Feasibility Trial of One-carbon Metabolism Cofactor Supplements for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Source: ClinicalTrials.gov · Last updated 27 Nov 2024
Brief summary (registry, in English)
The purpose of the study is to assess the feasibility of a trial to test the effects of homocysteine (Hcy) lowering supplements in patients with NAFLD. NAFLD patients will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of approximately 12 to 13 weeks, participants will complete two in person visits and two phone visits to complete activities such as physical exam, fibroscan, blood draws, and questionnaires.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 31 Jan 2023
- Start date
- 30 Jun 2023
- Primary completion date
- 23 Aug 2024
- Lead sponsor
- Duke University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05720702
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 31
- From 30 Jun 2023 to the primary completion date, 23 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent use of steatogenic medications
Other illness
- Clinical diagnosis of cirrhosis or other chronic liver diseases
- Chronic kidney disease
- Any clinical conditions associated with malabsorption
- Any active diagnosis of malignancy
Other
- Any contraindication to the study supplements
- Inability to obtain valid fibroscan measures at the screening
- Pregnancy or lactation
- Excess alcohol use (\>21/ \>14 drinks weekly in men/women)
- Supplement use within 30 days, containing any of the study supplements
- Total parenteral nutrition
- Use of immunosuppression
Who the study is looking for
- Increased hepatic fat accumulation diagnosed by either abdominal ultrasound or CT AND elevated CAP score of 280 dB/m or higher
- HOMA-IR ≥ 2 or the diagnosis of metabolic syndrome
- Chronic elevation of transaminases: ALT elevation (more than 2 times during the past 12 months, defined by 19 U/L for women and 30 U/L for men 31)
- Stable use of any potential anti-NASH therapy (i.e., vitamin E, pioglitazone, glucagon like peptide 1 agonist, etc.) for 6 months prior to screening.
- Aged 18+ years
- Able to provide legal consent
Criteria the registry did not label
- We will enroll NAFLD patients, blocked by age 50 years (≤ 50; \> 50) and sex (M; F, four patients/subjects in each block).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.