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Vitamin D and Calcium Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857831
First Posted: March 9, 2009
Last Update Posted: October 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
VA Office of Research and Development
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin D and Calcium Replacement/Supplementation in Subjects With Chronic Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Effects of Vitamin D and Calcium supplements on calcium metabolism and vitamin D deficiency [ Time Frame: 15-20 weeks ]

Estimated Enrollment: 10
Study Start Date: January 2008
Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Spinal Cord Injury (paraplegia or quadriplegia)
  • Vitamin D deficiency
  • Absolute deficient Vitamin D [25(OH)D] < 16 ng/ml
  • Relative deficient Vitamin D [25(OH)D] <30ng/ml - participation in the FES/SRT study at Kessler Institute for Rehabilitation

Exclusion Criteria:

  • History of kidney stones
  • History of bone disorders
  • Currently pregnant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857831


Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Kessler Foundation
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00857831     History of Changes
Other Study ID Numbers: B4162C-8
First Submitted: March 5, 2009
First Posted: March 9, 2009
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by VA Office of Research and Development:
spinal cord injury
Vitamin D deficiency
Functional Electrical Stimulation

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents