Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801849
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2021-03-12
Brief Title:
Vitamin E Dosing Study
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Vitamin E Dosing Study VEDS a Dose Finding Study of Vitamin E for the Treatment of Adult NAFLD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
VEDS
Brief Summary:
This is a multicenter randomized double masked placebo-controlled parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease NAFLD
Detailed Description:
Adults age 18 years or older will be enrolled for 48 weeks and treated with 200 international units IU 400 IU or 800 IU of Vitamin E or matching placebo for 24 weeks The primary objective of the study is to determine the minimum effective dose of Vitamin E d-alpha-tocopherol based upon relative change in alanine aminotransferase ALT from baseline to 24 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24DK061730 | NIH | None | None |
| U01DK061732 | NIH | None | None |
| U01DK061713 | NIH | None | None |
| U01DK061737 | NIH | None | None |
| U01DK061728 | NIH | None | None |
| U01DK061718 | NIH | None | None |
| U01DK061734 | NIH | None | None |
| U01DK061738 | NIH | None | None |
| U01DK061731 | NIH | None | httpsreporternihgovquickSearchU01DK061731 |