NCT01354964

Brief Summary

The purpose of this research is to study the effects of Vitamin D supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation, and on specific cells and processes in fat tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2

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 13, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2015

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 9, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

6.2 years

First QC Date

May 12, 2011

Results QC Date

April 12, 2019

Last Update Submit

October 9, 2020

Conditions

Insulin Resistance

Keywords

Glucose Metabolism DisordersInsulin ResistanceEndocrine SystemVitamin D

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Hepatic Insulin Sensitivity

    Endogenous glucose production (EGP) was assessed at each study visit to evaluate hepatic insulin sensitivity. Percent change between the EGP at baseline and second visit (after treatment for up to 3 months with Vitamin D to reach a target level of ≥30 ng/ml), and baseline and third visits (after treatment for up to 6 months with Vitamin D in order to reach a target level of ≥50 ng/ml) will be calculated.

    2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months)

Secondary Outcomes (5)

  • Percent Change in Peripheral Glucose Uptake

    2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

  • Evaluated Expression of Pro-inflammatory Gene TNF-α

    2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

  • Evaluated Expression of Pro-inflammatory Gene IL-6

    2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

  • Evaluated Expression of Pro-inflammatory Gene iNOS

    2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

  • Evaluated Expression of Pro-inflammatory Gene PAI-1

    2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

Study Arms (2)

Vitamin D

EXPERIMENTAL

Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to six months.

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months.

Drug: Placebo

Interventions

Vitamin DDRUG
Also known as: Vitamin D3 (cholecalciferol)
Vitamin D
PlaceboDRUG
Placebo

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Serum 25(OH)D\<20ng/ml
  • Insulin Resistant based on HOMA-IR score of \>3
  • Able and willing to provide informed consent
  • BMI 20-35

You may not qualify if:

  • HIV/AIDS
  • History of any cancer
  • Sarcoidosis
  • Alcohol or substance abuse
  • Cushing's syndrome
  • Primary hyperparathyroidism
  • Nephrolithiasis
  • Pregnancy or breastfeeding
  • Regular visits to a tanning salon
  • Hypercalcemia or hypocalcemia
  • Untreated or uncontrolled hypertension
  • Any chronic illness requiring medication, other than arthritis, hypertension and hyperlipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Insulin ResistanceGlucose Metabolism Disorders

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

HyperinsulinismMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Meredith Hawkins
Organization
Albert Einstein College of Medicine
meredith.hawkins@einsteinmed.org
7184302903

Study Officials

  • Meredith A Hawkins, M.D., M.S.

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine (Endocrinology)

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 17, 2011

Study Start

March 13, 2009

Primary Completion

June 3, 2015

Study Completion

September 3, 2015

Last Updated

November 2, 2020

Results First Posted

March 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)