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OpenTrials
Completed

NCT Number: NCT03084328

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 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.

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Key information

Conditions

Nonalcoholic Fatty Liver Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults of age 18 or greater
  • Diagnosis of fatty liver disease with a low Vitamin D level (< 30 ng/dl) in the past 6 months
  • Able to give consent

Exclusion criteria

  • Those currently receiving Vitamin D supplementation

Treatment and study plan

Vitamind D

Dietary Supplement

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

Primary outcomes

  1. Change in vitamin D levels

    Time frame: Baseline and 6 months

    Change in plasma vitamin D levels from baseline to 6 months

  2. Change in liver and renal function

    Time frame: Baseline and 6 months

    Change in hepatic function panel and renal function panel from baseline to 6 months

  3. Change in body composition data

    Time frame: Baseline and 6 months

    Change in blood pressure, waist circumference, BIA and CT scan if performed clinically

  4. Chang in lipid profile

    Time frame: Baseline and 6 months

    Change in HDL, LDL, and TG from baseline to 6 months

  5. Change in insulin resistance

    Time frame: Basline and 6 months

    Change in insulin resistance from baseline to 6 months

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Mar 20, 2017
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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