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

NCT02099955 | Completed Phase 1 FDA Drug

• 1 other identifier: BAU-11-092
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Vitamin D Deficiency

Keywords

spinal cord injury; vitamin D deficiency; pulmonary function; metabolic diseases

Outcome Measures

Primary Outcomes (1)

• Number of SCI participants with vitamin D deficiency

  Vitamin D levels will be obtained during screening.

  Screening study (1 visit, 2 hours)

Secondary Outcomes (1)

• Pulmonary function improvement as measured by PFTs in SCI with increased vitamin D levels

  Change from baseline at 6 months

Other Outcomes (3)

• Pulmonary function improvement as measured by inflammation in SCI with vitamin D supplementation.

  Change from baseline at 6 months

• Impaired glucose tolerance (IGT) improvement in SCI with vitamin D supplementation

  Change from baseline at 6 months

• Musculoskeletal pain improvement with vitamin D supplementation

  Change from baseline at 6 months

Study Arms (3)

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).

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.

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

4000 IU/day or 2000 IU/day for 12 weeks

Also known as: Cholecalciferol

Endocrine Arm; Pulmonary Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 75,
• Chronic (\>1 year) SCI; tetraplegia (C3-8), paraplegia, (T1-6)

You may not qualify if:

• 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
• Between the ages of 18 and 75,
• Chronic SCI (\>1 year, C3-T6)
• Vitamin D deficiency as defined as a value \<20 ng/ml.
• 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.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Vitamin D Deficiency; Metabolic Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• William Bauman, M.D.

  James J Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Center Director

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: March 31, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

US (1)