Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation

Albert Einstein College of Medicine

Status and phase: Completed; Phase 2

Conditions: Insulin Resistance

Treatments: Drug: Vitamin D; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01354964

5K23RR023335-02 (U.S. NIH Grant/Contract)

2008-225

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

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

Treatment:

Drug: Vitamin D

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo