Vitamin D Deficiency and Replacement on Pulmonary and Endocrine Function in SCI
Spinal Cord Injury, Vitamin D Deficiency
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, vitamin D deficiency, pulmonary function, metabolic diseases
Eligibility Criteria
Part 1: Screening for Vitamin D Deficiency
Inclusion Criteria:
- Between the ages of 18 and 75,
- Chronic (>1 year) SCI; tetraplegia (C3-8), paraplegia, (T1-6)
Exclusion Criteria:
- Acute illness
- Acute drug or alcohol use
- Lack of mental capacity to give informed consent,
- Pregnancy,
- Currently receiving Vitamin D supplementation.
Part 2A: Vitamin D and Pulmonary Function
Inclusion Criteria:
- Between the ages of 18 and 75,
- Chronic SCI (>1 year, C3-T6)
- Vitamin D deficiency as defined as a value <20 ng/ml.
Exclusion Criteria:
- Smoking, active or history of smoking during life time,
- Any history of blast injuries to the chest,
- Active respiratory disease,
- Pregnancy,
- Lack of mental capacity to give informed consent.
- Recent (within 3 months) respiratory infection.
- Receiving medications known to alter airway caliber.
- Acute drug or alcohol use,
- Currently receiving Vitamin D supplementation > 1000 units/day.
Part 2B: Vitamin D, Carbohydrate Metabolism, and Insulin Resistance
Inclusion Criteria:
- Between the ages of 18 and 75,
- Chronic SCI (>1 year, C3-T6)
- Vitamin D deficiency as defined as a value <20 ng/ml,
- Insulin Resistance (IR), Impaired glucose tolerance (IGT), and/or Diabetes Mellitus (DM).
Exclusion Criteria:
- Pregnancy,
- Problems with the kidneys,
- Lack of mental capacity to give informed consent,
- Acute drug or alcohol use,
- Currently receiving Vitamin D supplementation > 1000 units/day.
Sites / Locations
- James J Peters VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Screening Study
Pulmonary Arm
Endocrine Arm
To determine the prevalence and severity of vitamin D deficiency and glucose tolerance in persons with chronic SCI.
Vitamin D3 Supplementation and Pulmonary Function: To determine the relationship between levels of vitamin D and overall pulmonary function, as measured by PFTs (spirometry and body plethysmography). To determine effects of vitamin D supplementations on overall pulmonary function and selected biomarkers of inflammation (FeNO, pH, 8- isoprostane levels).
Vitamin D3 Supplementation and Endocrine Function: To determine the effect of vitamin D replacement therapy on carbohydrate metabolism and insulin resistance in persons with vitamin D deficiency (<20ng/ml) and IGT, mild DM (e.g. fasting serum glucose <140 mg/dL) and/or IR.