NCT04038853

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2015

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

July 22, 2019

Last Update Submit

July 28, 2019

Conditions

Non-alcoholic Fatty Liver DiseaseVitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

  • Elastographic parameter of steatosis

    Change of elastographic parameter of steatosis (Controlled Attenuation Parameter; CAP) during the 6 and 12 months period

    Week 0 - initiation; after 6 months; and after 12 months (end of study)

  • Elastographic parameter of fibrosis

    Change of elastographic parameter of fibrosis (liver stiffness measurements; LSM) during the 6 and 12 months period

    Week 0 - initiation; after 6 months; and after 12 months (end of study)

Secondary Outcomes (8)

  • Aspartate transaminase

    Week 0 - initiation; after 6 months; and after 12 months (end of study)

  • Alanine transaminase

    Week 0 - initiation; after 6 months; and after 12 months (end of study)

  • Gamma-glutamyl transferase

    Week 0 - initiation; after 6 months; and after 12 months (end of study)

  • Insuline Resistance

    Week 0 - initiation; after 6 months; and after 12 months (end of study)

  • Total cholesterol

    Week 0 - initiation; after 6 months; and after 12 months (end of study)

  • +3 more secondary outcomes

Study Arms (2)

Vitamin D

EXPERIMENTAL

Intervention drug, containing 1,25-dihydroxy-vitamin D, comes in original packages as vials containing a total amount of 10 ml of clear solution. 5 drops accounting for 1000 IU of 1,25-dihydroxy-vitamin D will be administered orally on a daily basis.

Drug: 1,25-Dihydroxyvitamin D

Placebo

PLACEBO COMPARATOR

A placebo identical to the study intervention drug in all its characteristics (package, visual characteristics of the fluid, smell, and taste) will be administered in the same manner.

Drug: Placebo

Interventions

1,25-Dihydroxyvitamin DDRUG

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

Also known as: 1,25-Dihydroxy-Cholecalciferol, Cholecalciferol, Vitamin D3
Vitamin D
PlaceboDRUG

Placebo identical to the study intervention drug

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
  • signed informed consent
  • possibility to follow instruction and the protocol

You may not qualify if:

  • chronic B or C hepatitis
  • chronic kidney insufficiency (grade 4 and 5), hemodialysis
  • any other chronic liver disease
  • opioid dependancy
  • any malignancy
  • HIV seropositivity
  • alcohol abuse
  • pregnancy
  • inability to follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseVitamin D Deficiency

Interventions

1,25-dihydroxyvitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Ivana Mikolasevic, MD, PhD

    Department of Gastroenterology, Clinical Hospital Center Rijeka, University of Rijeka, Croatia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 31, 2019

Study Start

December 1, 2015

Primary Completion

February 1, 2017

Study Completion

April 1, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share