Vitamin D Deficiency and Replacement on Pulmonary and Endocrine Function in SCI
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Hospital, Hospital, Orthopedic, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/8/2017 |
| Start Date: | January 2012 |
| End Date: | December 2016 |
Effects of Vitamin D Deficiency and Its Replacement on Pulmonary and Endocrine Function in Persons With SCI
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.
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.
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.
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.
We found this trial at
1
site
Bronx, New York 10468
Principal Investigator: William Bauman, M.D.
Phone: 718-584-9000
Click here to add this to my saved trials
