search
Back to results

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

Primary Purpose

Spinal Cord Injury, Vitamin D Deficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, vitamin D deficiency, pulmonary function, metabolic diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • James J Peters VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Screening Study

Pulmonary Arm

Endocrine Arm

Arm Description

To determine the prevalence and severity of vitamin D deficiency and glucose tolerance in persons with chronic SCI.

Vitamin D3 Supplementation and Pulmonary Function: To determine the relationship between levels of vitamin D and overall pulmonary function, as measured by PFTs (spirometry and body plethysmography). To determine effects of vitamin D supplementations on overall pulmonary function and selected biomarkers of inflammation (FeNO, pH, 8- isoprostane levels).

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.

Outcomes

Primary Outcome Measures

Number of SCI participants with vitamin D deficiency
Vitamin D levels will be obtained during screening.

Secondary Outcome Measures

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.

Full Information

First Posted
December 5, 2013
Last Updated
March 6, 2017
Sponsor
James J. Peters Veterans Affairs Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02099955
Brief Title
Vitamin D Deficiency and Replacement on Pulmonary and Endocrine Function in SCI
Official Title
Effects of Vitamin D Deficiency and Its Replacement on Pulmonary and Endocrine Function in Persons With SCI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
James J. Peters Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Vitamin D Deficiency
Keywords
spinal cord injury, vitamin D deficiency, pulmonary function, metabolic diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening Study
Arm Type
No Intervention
Arm Description
To determine the prevalence and severity of vitamin D deficiency and glucose tolerance in persons with chronic SCI.
Arm Title
Pulmonary Arm
Arm Type
Experimental
Arm Description
Vitamin D3 Supplementation and Pulmonary Function: To determine the relationship between levels of vitamin D and overall pulmonary function, as measured by PFTs (spirometry and body plethysmography). To determine effects of vitamin D supplementations on overall pulmonary function and selected biomarkers of inflammation (FeNO, pH, 8- isoprostane levels).
Arm Title
Endocrine Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
4000 IU/day or 2000 IU/day for 12 weeks
Primary Outcome Measure Information:
Title
Number of SCI participants with vitamin D deficiency
Description
Vitamin D levels will be obtained during screening.
Time Frame
Screening study (1 visit, 2 hours)
Secondary Outcome Measure Information:
Title
Pulmonary function improvement as measured by PFTs in SCI with increased vitamin D levels
Description
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
Other Pre-specified Outcome Measures:
Title
Pulmonary function improvement as measured by inflammation in SCI with vitamin D supplementation.
Description
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
Title
Impaired glucose tolerance (IGT) improvement in SCI with vitamin D supplementation
Description
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
Title
Musculoskeletal pain improvement with vitamin D supplementation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Bauman, M.D.
Organizational Affiliation
James J Peters VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs