Vitamin D Deficiency and Replacement on Pulmonary and Endocrine Function in SCI
Condition: Spinal Cord Injury; Vitamin D Deficiency
MeSH terms: Spinal Cord Injuries; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): 4000 IU/day or 2000 IU/day for 12 weeks
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; vitamin D deficiency; pulmonary function; metabolic diseases