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Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Albert Einstein College of Medicine, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01354964
First Posted: May 17, 2011
Last Update Posted: May 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Albert Einstein College of Medicine, Inc.
  Purpose
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/or on specific cells and processes in fat tissue, and on function of skeletal muscle and joints.

Condition Intervention Phase
Insulin Resistance Drug: Vitamin D Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine, Inc.:

Primary Outcome Measures:
  • Hepatic insulin sensitivity [ Time Frame: 2 and 4 months ]
    We will examine endogenous glucose production to assess hepatic insulin sensitivity.


Secondary Outcome Measures:
  • Peripheral insulin sensitivity [ Time Frame: 2 and 4 months ]
    We will examine the rate of glucose uptake to determine peripheral inslin sensitivity.

  • Adipose tissue inflammatory markers/Cytokines in plasma [ Time Frame: 2 and 4 months ]
    Inflammatory markers-PAI-1, IL-6, TNF-a, iNOS

  • Neuropsychological Testing [ Time Frame: 4 months ]
    We will conduct neuropsychological testing to assess cognitive function.


Estimated Enrollment: 25
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Vitamin D
Drug: Vitamin D
Weekly oral vitamin D drops, weight-based calculated dosage, taken on the same day each week for 4 months.

Detailed Description:
Over the last several years, studies have shown that low vitamin D levels may increase risk of development of Type 2 Diabetes. The investigators will administer vitamin D3 (Cholecalciferol) to nondiabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels < 20 ng/ml) to increase the level of vitamin D initially to 30-50ng/ml and then to higher normal range of 51-75 ng/ml. The investigators will study its effects on insulin action, adipose tissue inflammation, and musculoskeletal function.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21-60 years old
  • Serum 25(OH)D<20ng/ml
  • Insulin Resistant based on HOMA-IR score of >3
  • Able and willing to provide informed consent
  • BMI 27-35

Exclusion Criteria:

  • FPG greater than or equal to 126 mg/dl or 2-hour-OGTT plasma glucose greater than or equal to 200 mg/dl
  • Diagnosed diabetes mellitus
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354964


Contacts
Contact: Stephanie M Lawrence, BS 718-430-2903 stephanie.lawrence@einstein.yu.edu

Locations
United States, New York
Albert Einstein College of Medicine of Yeshiva University Recruiting
Bronx, New York, United States, 10461
Contact: Stephanie Lawrence, BS    718-430-2903    stephanie.lawrence@einstein.yu.edu   
Principal Investigator: Preeti Kishore, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Preeti Kishore, MD Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Preeti Kishore, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01354964     History of Changes
Other Study ID Numbers: 2008-225
First Submitted: May 12, 2011
First Posted: May 17, 2011
Last Update Posted: May 17, 2011
Last Verified: May 2011

Keywords provided by Albert Einstein College of Medicine, Inc.:
Glucose Metabolism Disorders
Insulin Resistance
Endocrine System
Vitamin D

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Vitamins
Vitamin D
Ergocalciferols
Hypoglycemic Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Bone Density Conservation Agents