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NCT03084328 · ClinicalTrials.gov registry record
Vitamin D Replacement in Nonalcoholic Fatty Liver Disease
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 48
- Enrollment target
NCT03084328: Completed study, sponsored by The Cleveland Clinic.
NCT03084328 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03084328 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 48 participants
- Enrollment target
Study Summary
Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our observations in the Metabolic Liver Clinic and that reported by others. We also observed that patients with more severe fatty liver disease had lower Vitamin D concentrations. Others have shown that replacing Vitamin D in patients with cirrhosis is effective and even patients with Vitamin D replete status have lowering of Vitamin D over time if not supplemented. One of the measures of liver injury in NAFLD is the plasma concentration of ALT and we will use this to follow patients as is currently done as standard of care. All patients in the Metabolic Liver Clinic are being routinely screened for Vitamin D deficiency as standard of care and treatment is being started with oral supplementation, but there are not standardized protocols to determine success of therapy. We hypothesize that patients with NAFLD with low Vitamin D levels will respond appropriately to Vitamin D supplementation for 6 months.
Primary Outcome
Change in plasma vitamin D levels from baseline to 6 months
Interventions
- DIETARY_SUPPLEMENT Vitamind D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-01-20 |
| Est. Completion | 2017-03-10 |
What the finished NCT03084328 record still lists
NCT03084328 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 48 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Vitamind D is the first listed.
NCT03084328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03084328 about?
NCT03084328 is a clinical study titled "Vitamin D Replacement in Nonalcoholic Fatty Liver Disease". Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our observations in the Metabolic Liver Clinic and that reported by others. We also observed that patients with more severe fatty liver disease had lower Vitamin D concentrations. Others have shown that replacin...
What is the current status of trial NCT03084328?
This trial is currently completed. The enrollment target is 48 participants. The study started on 2012-01-20. Estimated completion is 2017-03-10.
What interventions are being tested in trial NCT03084328?
The interventions under investigation include: Vitamind D (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03084328?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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