Spinal Cord Injury, Vitamin D Deficiency
Conditions
Keywords
spinal cord injury, vitamin D deficiency, pulmonary function, metabolic diseases
Brief summary
Studies have shown that individuals who have suffered a spinal cord injury are at an increased risk of Vitamin D deficiency compared to able-bodied individuals. It has recently been shown that Vitamin D deficiency is linked to a large number of diseases and conditions, including chronic lung disease, vascular problems, and insulin resistance. If this common nutritional deficiency is proven to be the cause of some of these diseases and conditions in persons with SCI, then it may easily be remedied with a cheap and effective therapeutic approach: vitamin D replacement therapy. Because of the high prevalence of vitamin D deficiency in persons with SCI, this therapy alone or in combination with other treatment options will be expected to significantly improve overall well being in the SCI population, decrease hospitalization rate, and the lower the financial burden of care.
Detailed description
Vitamin D deficiency is prevalent in individuals with Spinal Cord Injury (SCI). Recent studies have linked vitamin D with the prevention and/or treatment of a wide range of diseases, including chronic lung diseases. Patients with chronic lung diseases appear to be at increased risk for vitamin D deficiency for reasons that are not clear. Chronic lung diseases such as asthma and chronic obstructive lung disease (COPD) have been linked to vitamin D on a genetic basis. A recent observational study found a significant association between vitamin D deficiency and decreased pulmonary function in a large able-bodied population. The exact mechanisms involved have not been identified, but it has been postulated that vitamin D possesses a range of anti-inflammatory properties involving modulation of oxidative stress, or, possibly, protease/antiprotease balance and tissue damage/repair, mechanisms that have been shown to be important in the pathogenesis of chronic lung diseases. The relationship between vitamin D and the immune system is of utmost importance given that individuals with high cervical lesions express many obstructive aspects of pulmonary physiology commonly observed in individuals with asthma, in whom airway inflammation represents an underlying pathophysiological mechanism. In addition to a high prevalence of vitamin D deficiency, persons with SCI have a higher prevalence of insulin resistance (IR), impaired glucose tolerance (IGT) and diabetes mellitus (DM). In the general population, vitamin D deficiency has been shown to be associated with IR, IGT and DM. If treatment of vitamin D deficiency in persons with SCI is shown to be associated with improvement in insulin sensitivity and reductions in impaired glucose tolerance or DM, then progression to more severe carbohydrate disorders may be delayed or prevented.
Interventions
DRUGVitamin D3
4000 IU/day or 2000 IU/day for 12 weeks
Sponsors
James J. Peters Veterans Affairs Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of SCI participants with vitamin D deficiency | Screening study (1 visit, 2 hours) | Vitamin D levels will be obtained during screening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function improvement as measured by PFTs in SCI with increased vitamin D levels | Change from baseline at 6 months | Pulmonary function change will be measured in vitamin D deficient SCI subjects by spirometry and body plethysmography at baseline, 3 months, and 6 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function improvement as measured by inflammation in SCI with vitamin D supplementation. | Change from baseline at 6 months | Pulmonary function change will be measured in vitamin D deficient SCI subjects by biomarkers of inflammation, such as FeNO, pH, and 8-isoprostane, at baseline, 3 months, and 6 months. |
| Impaired glucose tolerance (IGT) improvement in SCI with vitamin D supplementation | Change from baseline at 6 months | Vitamin D deficient SCI subjects with IGT and/or IR will undergo vitamin D replacement therapy. Glucose and insulin levels will be measured at baseline, 3 months, and 6 months. |
| Musculoskeletal pain improvement with vitamin D supplementation | Change from baseline at 6 months | Vitamin D deficient SCI subjects will complete a pain survey at baseline, 3 months, and 6 months to assess musculoskeletal pain and how it may improve with vitamin D supplementation. |
Countries
United States
Outcome results
None listed