Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-13 @ 2:12 PM
Study NCT ID:
NCT05720702
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2023-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Trial of OCM Supplements for the Treatment of NAFLD
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
A Feasibility Trial of One-carbon Metabolism Cofactor Supplements for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: