Trials / Completed
CompletedNCT05720702
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)
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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. During the in person visits NAFLD participants will complete the following activities: * Review medical history * Physical examination * Vital signs (blood pressure, heart rate, respiratory rate, body temperature) * Measure height, weight, body mass index, and waist circumference * Grip test * Fasting blood tests * Pregnancy test (if applicable) * Fibroscan with CAP score * QOL questionnaire
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | homocysteine (Hcy) lowering supplements | NAFLD participants will take homocysteine (Hcy) lowering supplements daily for 12 weeks. |
Timeline
- Start date
- 2023-06-30
- Primary completion
- 2024-08-23
- Completion
- 2024-08-23
- First posted
- 2023-02-09
- Last updated
- 2024-11-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05720702. Inclusion in this directory is not an endorsement.