Spinal Cord InjuryPhase 1/2NCT02099955
Vitamin D Deficiency and Replacement on Pulmonary and Endocrine Function in SCI
A Phase 1/2 study testing Vitamin D3 in people with Spinal Cord Injury and Vitamin D Deficiency, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 75,
- Chronic (>1 year) SCI; tetraplegia (C3-8), paraplegia, (T1-6)
- Between the ages of 18 and 75,
- Chronic SCI (>1 year, C3-T6)
- Vitamin D deficiency as defined as a value <20 ng/ml.
- Between the ages of 18 and 75,
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- 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).
Who cannot join
- 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
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury, Vitamin D Deficiency
- Being tested
- Vitamin D3
- Keywords
- spinal cord injury, vitamin D deficiency, pulmonary function, metabolic diseases
- Medical subject headings
- Spinal Cord Injuries, Vitamin D Deficiency, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Cholecalciferol
4000 IU/day or 2000 IU/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Screening Study | No intervention | To determine the prevalence and severity of vitamin D deficiency and glucose tolerance in persons with chronic SCI. |
| Pulmonary Arm | Experimental | 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). Receives: Drug: Vitamin D3 |
| Endocrine Arm | Experimental | 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. Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of SCI participants with vitamin D deficiency
Vitamin D levels will be obtained during screening.
Measured: Screening study (1 visit, 2 hours)
Secondary outcomes (1)
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.
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- William Bauman, M.D., Principal investigator, James J Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099955
- Sponsor's protocol ID
- BAU-11-092
- Status last verified
- Mar 2017
- First submitted
- 5 Dec 2013
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Deficiency and Its Replacement on Pulmonary and Endocrine Function in Persons With SCI
- ClinicalTrials.gov ID
- NCT02099955
- Acronym / sponsor ID
- BAU-11-092
- Conditions
- Spinal Cord Injury, Vitamin D Deficiency
- Keywords
- spinal cord injury, vitamin D deficiency, pulmonary function, metabolic diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening Study | No intervention | –To determine the prevalence and severity of vitamin D deficiency and glucose tolerance in persons with chronic SCI. |
| Pulmonary Arm | Experimental | Drug: Vitamin D3Vitamin 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). |
| Endocrine Arm | Experimental | Drug: Vitamin D3Vitamin 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between the ages of 18 and 75,
- Chronic (>1 year) SCI; tetraplegia (C3-8), paraplegia, (T1-6)
- Between the ages of 18 and 75,
- Chronic SCI (>1 year, C3-T6)
- Vitamin D deficiency as defined as a value <20 ng/ml.
Key exclusion criteria (21 listed)
- Acute illness
- Acute drug or alcohol use
- Lack of mental capacity to give informed consent,
- Pregnancy,
- Currently receiving Vitamin D supplementation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: Cholecalciferol4000 IU/day or 2000 IU/day for 12 weeks | Drug | Endocrine Arm, Pulmonary Arm |
Primary outcome
Number of SCI participants with vitamin D deficiency
Time frame: Screening study (1 visit, 2 hours)
Vitamin D levels will be obtained during screening.
1 secondary outcome
Pulmonary function improvement as measured by PFTs in SCI with increased vitamin D levels
Time frame: Change from baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Spinal Cord Damage Research Center websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Bauman, M.D. principal investigator
James J Peters VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D3 in people with Spinal Cord Injury and Vitamin D Deficiency, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SCI participants with vitamin D deficiency (time frame: Screening study (1 visit, 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.