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Dietary Supplement

Hcy Lowering Supplements for Non-alcoholic Fatty Liver Disease

N/A

Recruiting

Led By Ayako Suzuki

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial will assess the effects of Hcy-lowering supplements on NAFLD patients. Supplements taken daily for 12 weeks, with physical exams, blood draws, & questionnaires.

Who is the study for?

This trial is for adults over 18 with Non-alcoholic Fatty Liver Disease (NAFLD), who have increased liver fat confirmed by ultrasound or CT, a high CAP score, insulin resistance or metabolic syndrome, and chronic elevated liver enzymes. Participants must have been on stable NAFLD treatments for at least 6 months.Check my eligibility

What is being tested?

The study tests if homocysteine-lowering supplements (Vitamin B12, Folate, Vitamin B6, Betaine) taken daily can benefit those with NAFLD. Over about 3 months, participants will visit the clinic twice and have two phone calls to check their health status through exams and questionnaires.See study design

What are the potential side effects?

Potential side effects of the supplements may include allergic reactions, mild digestive upset like nausea or diarrhea, headache, feeling of being fullness or loss of appetite. However specific side effects related to this trial are not detailed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

FibroScan-aspartate aminotransferase (FAST) score

Secondary outcome measures

Assess safety of the trial.

Feasibility as measured by percentage of completion of enrollment

Trial Design

1Treatment groups

Experimental Treatment

Group I: NAFLD GroupExperimental Treatment1 Intervention

The NAFLD group 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,622 Total Patients Enrolled

8 Trials studying Non-alcoholic Fatty Liver Disease

2,744 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Ayako SuzukiPrincipal InvestigatorDuke University

1 Previous Clinical Trials

70 Total Patients Enrolled

1 Trials studying Non-alcoholic Fatty Liver Disease

70 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Non-alcoholic Fatty Liver Disease Research Study Groups: NAFLD Group

Homocysteine (Hcy) lowering supplements (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05720702 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently looking to enroll participants?

"Affirmative. According to data from clinicaltrials.gov, enrollment for this medical trial is still ongoing - first posted on June 30th of 2023 and last updated July 17th of the same year. This study requires a total of 20 participants at one designated site."

Answered by AI

How many participants are being admitted to this clinical research?

"That is correct. The clinical trial registry hosted on clinicaltrials.gov indicates that this particular study, which was first posted on June 30th 2023, is still actively recruiting participants with 1 location requiring up to 20 enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Feasibility Trial of OCM Supplements for the Treatment of NAFLD

2023. "A Feasibility Trial of OCM Supplements for the Treatment of NAFLD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05720702.

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