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Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation

NCT ID: NCT01354964

Last Updated: 2020-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-13

Study Completion Date

2015-09-03

Brief Summary

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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.

Detailed Description

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Over the last several years, studies have shown that low vitamin D levels may increase risk of developing Type 2 Diabetes. The investigators will administer vitamin D3 (cholecalciferol) to non-diabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels \<20 ng/ml) to increase the level of vitamin D3. The investigators will study the effects of increased Vitamin D on insulin action, adipose tissue inflammation, and on certain cells and processes in fat tissue.

Investigators will study participants with a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Adipose tissue inflammation will be measured using the following inflammatory markers: IL-6, PAI-1, TNF-alpha, and iNOS.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vitamin D

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Vitamin D3 (cholecalciferol)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Meredith Hawkins

Professor of Medicine (Endocrinology)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meredith A Hawkins, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5K23RR023335-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008-225

Identifier Type: -

Identifier Source: org_study_id