CompletedPhase 1/2

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

United States88 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of SCI participants with vitamin D deficiency

Timeframe: Screening study (1 visit, 2 hours)

Trial details

NCT IDNCT02099955

SponsorJames J. Peters Veterans Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Spinal Cord Injury trials