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Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

NCT03084328 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2017-04-13

No results posted yet for this 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.

Conditions

  • Nonalcoholic Fatty Liver

Interventions

DIETARY_SUPPLEMENT

Vitamind D

Patients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-20
Primary Completion
2014-12-20
Completion
2017-03-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084328 on ClinicalTrials.gov