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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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.