A Phase 1/2 interventional study of Vitamin D3 in Spinal Cord Injury and Vitamin D Deficiency, sponsored by James J. Peters Veterans Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-07.
Sponsored by James J. Peters Veterans Affairs Medical Center · Phase 1/2, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 88 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →James J. Peters Veterans Affairs Medical Center is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
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Part 1: Screening for Vitamin D Deficiency
Inclusion Criteria:
Exclusion Criteria:
Part 2A: Vitamin D and Pulmonary Function
Inclusion Criteria:
Exclusion Criteria:
Part 2B: Vitamin D, Carbohydrate Metabolism, and Insulin Resistance
Inclusion Criteria:
Exclusion Criteria:
To determine the prevalence and severity of vitamin D deficiency and glucose tolerance in persons with chronic SCI.
Vitamin D3 Supplementation and Pulmonary Function: 1. To determine the relationship between levels of vitamin D and overall pulmonary function, as measured by PFTs (spirometry and body plethysmography). 2. To determine effects of vitamin D supplementations on overall pulmonary function and selected biomarkers of inflammation (FeNO, pH, 8- isoprostane levels).
Drug: Vitamin D3
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.
Drug: Vitamin D3
4000 IU/day or 2000 IU/day for 12 weeks
Also known as: Cholecalciferol
Number of SCI participants with vitamin D deficiency
Vitamin D levels will be obtained during screening.
Time frame: Screening study (1 visit, 2 hours)
Pulmonary function improvement as measured by PFTs in SCI with increased vitamin D levels
Pulmonary function change will be measured in vitamin D deficient SCI subjects by spirometry and body plethysmography at baseline, 3 months, and 6 months.
Time frame: Change from baseline at 6 months
Pulmonary function improvement as measured by inflammation in SCI with vitamin D supplementation.
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.
Time frame: Change from baseline at 6 months
Impaired glucose tolerance (IGT) improvement in SCI with vitamin D supplementation
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.
Time frame: Change from baseline at 6 months
Musculoskeletal pain improvement with vitamin D supplementation
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.
Time frame: Change from baseline at 6 months
Plan to share: Undecided
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James J. Peters Veterans Affairs Medical Center