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Vitamin D in Fatty Liver Disease

NCT04038853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-07-31

No results posted yet for this study

Summary

This study evaluates the influence of vitamin D in reducing laboratory, elastographic (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive vitamin D (Plivit D3) while the other half will receive placebo

Conditions

  • Non-alcoholic Fatty Liver Disease
  • Vitamin D Deficiency

Interventions

DRUG

1,25-Dihydroxyvitamin D

1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months

DRUG

Placebo

Placebo identical to the study intervention drug

Sponsors & Collaborators

  • University of Rijeka

    collaborator OTHER

  • Pliva Hrvatska d.o.o.

    collaborator UNKNOWN

  • University Hospital Rijeka

    lead OTHER

Principal Investigators

  • Ivana Mikolasevic, MD, PhD · Department of Gastroenterology, Clinical Hospital Center Rijeka, University of Rijeka, Croatia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2017-02-01
Completion
2019-04-01

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Drugs

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 NCT04038853 on ClinicalTrials.gov