NCT02132442

Brief Summary

This study is designed to study the effect of vitamin D intake on the severity of fatty liver and poor glucose control in patients with type 2 diabetes and fatty liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Mar 2014

Typical duration for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

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

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

May 5, 2014

Last Update Submit

January 7, 2017

Conditions

Type 2 DiabetesNonalcoholic Fatty Liver DiseaseVitamin D Deficiency

Keywords

ChildrenAdolescentsAdultsType 2 diabetesNonalcoholic fatty liver diseaseVitamin D deficiency

Outcome Measures

Primary Outcomes (1)

  • Change in hepatic triglyceride content (HTGC)

    Change in hepatic triglyceride content (HTGC) as measured by proton magnetic resonance spectroscopy (1H MRS)

    6 months

Secondary Outcomes (1)

  • Hemoglobin A1c

    6 months

Study Arms (2)

Vitamin D supplementation

EXPERIMENTAL

Ergocalciferol 50,000 IU per week for 6 weeks, then bi-weekly for 6 mo

Dietary Supplement: Ergocalciferol, placebo

Placebo

PLACEBO COMPARATOR

Placebo capsules, on capsule per week for 6 weeks, then bi-weekly for 6 mo.

Dietary Supplement: Ergocalciferol, placebo

Interventions

Ergocalciferol, placeboDIETARY_SUPPLEMENT

Ergocalciferol 50000 IU capsules Microcrystalline cellulose

Also known as: Vitamin D, Placebo
PlaceboVitamin D supplementation

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children: 10 - 17 years
  • Adults: 18 - 50 years
  • Type 2 diabetes \> 6 mo duration
  • hydroxyvitamin D \[25(OH)D\] level of \<20 ng/mL
  • Hepatic triglyceride content (HTGC) value of \>5.6%
  • HbA1c of \> 8%;
  • Ability to take medication by mouth.

You may not qualify if:

  • Pregnant or lactating women
  • Mental deficiency (IQ \<70)
  • Chronic liver disease
  • Disorders of vitamin D metabolism, kidney, or parathyroid disease;
  • Calcium and/or vitamin D supplementation
  • Mauriac syndrome
  • Malabsorption of fat soluble vitamins
  • Drug toxicity and alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01609, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseaseVitamin D Deficiency

Interventions

ErgocalciferolsVitamin D

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFatty LiverLiver DiseasesDigestive System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Benjamin U Nwosu, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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
Associate Professor

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

US(1)