Vitamin D Deficiency and Replacement on Pulmonary and Endocrine Function in SCI

Vitamin D Deficiency Clinical Trial

Official title:

Effects of Vitamin D Deficiency and Its Replacement on Pulmonary and Endocrine Function in Persons With SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099955
• Other study ID #: BAU-11-092
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 5, 2013
• Last updated: March 6, 2017
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3
4000 IU/day or 2000 IU/day for 12 weeks

Locations

Country	Name	City	State
United States	James J Peters VA Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Change from baseline at 6 months
Other	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.	Change from baseline at 6 months
Other	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.	Change from baseline at 6 months
Primary	Number of SCI participants with vitamin D deficiency	Vitamin D levels will be obtained during screening.	Screening study (1 visit, 2 hours)
Secondary	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.	Change from baseline at 6 months

External Links

•   Spinal Cord Damage Research Center website