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| Sponsors and Collaborators: |
Department of Veterans Affairs Kessler Medical Rehabilitation Research Center |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00857831 |
Purpose
Vitamin D aids in the body's ability to absorb calcium, it is a vital component in bone formation and break down.
Reduced levels of vitamin D can indicate a vitamin deficiency and may depress serum calcium levels. The following is a list of common causes of vitamin D deficiency: lack of dairy products, alcohol usage, elderly, lack of exposure to sunlight, individuals with reduced mobility, GI malabsorption problems, dark complexion, severe liver damage, and renal failure. Many of these factors can be found in individuals with spinal cord injury. SCI results in disuse bone loss after acute injury, which continues with duration of injury. The goal of this study is to determine the effects of vitamin D and calcium supplements on calcium metabolism and vitamin D deficiency in individuals undergoing functional electrical stimulation (FES) stand retraining (SRT).
| Condition | Intervention |
|---|---|
|
Spinal Cord Injury |
Dietary Supplement: Vitamin D and Calcium |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Vitamin D and Calcium Replacement/Supplementation in Subjects With Chronic Spinal Cord Injury |
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Vitamin D & Calcium supplementation in FES
|
Dietary Supplement: Vitamin D and Calcium
2000 IU/day Vitamin D3 (cholecalciferol) and 1.3 g/day calcium carbonate will be taken for 15-20 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| VA Medical Center, Bronx | |
| Bronx, New York, United States, 10468 | |
| Principal Investigator: | William Bauman, MD | VA Medical Center, Bronx |
More Information
| Responsible Party: | Department of Veterans Affairs ( Bauman, William - Principal Investigator ) |
| Study ID Numbers: | B4162C-8 |
| Study First Received: | March 5, 2009 |
| Last Updated: | August 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00857831 History of Changes |
| Health Authority: | United States: Federal Government |
|
spinal cord injury Vitamin D deficiency Functional Electrical Stimulation |
|
Vitamin D Deficiency Cholecalciferol Spinal Cord Diseases Ergocalciferol Wounds and Injuries Ergocalciferols Central Nervous System Diseases Disorders of Environmental Origin Trace Elements Bone Density Conservation Agents |
Trauma, Nervous System Calcium Carbonate Spinal Cord Injuries Calcium, Dietary Vitamin D Vitamin D2 Vitamin D3 Vitamins Calciferol Micronutrients |
|
Spinal Cord Diseases Growth Substances Nervous System Diseases Physiological Effects of Drugs Wounds and Injuries Ergocalciferols Central Nervous System Diseases Disorders of Environmental Origin |
Bone Density Conservation Agents Trauma, Nervous System Pharmacologic Actions Spinal Cord Injuries Vitamin D Vitamins Micronutrients |
