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NCT03084328

Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

Completed Last updated 13 April 2017
What this trial tests

trial testing Vitamind D in Nonalcoholic Fatty Liver in 48 participants. Completed in 10 March 2017.

Timeline
20 January 2012
Primary endpoint
20 December 2014
10 March 2017

Quick facts

Lead sponsorThe Cleveland Clinic
StatusCompleted
Study typeOBSERVATIONAL
Enrollment48
Start date20 January 2012
Primary completion20 December 2014
Estimated completion10 March 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Nonalcoholic Fatty Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Addressing the heterogeneity in liver diseases using biological networks.
    Lam S, Doran S, Yuksel HH, Altay O, et al · · 2021 · cited 5× · PMID 32201876 · DOI 10.1093/bib/bbaa002

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Other recruiting trials for Nonalcoholic Fatty Liver

Currently open trials in the same condition.

Other The Cleveland Clinic trials

Trials by the same sponsor.

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Data sources for this page

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