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Vitamin D and Calcium Study

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D and Calcium
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, Vitamin D deficiency, Functional Electrical Stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Medical Center, Bronx

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Vitamin D & Calcium supplementation in FES

Outcomes

Primary Outcome Measures

Effects of Vitamin D and Calcium supplements on calcium metabolism and vitamin D deficiency

Secondary Outcome Measures

Full Information

First Posted
March 5, 2009
Last Updated
October 2, 2012
Sponsor
US Department of Veterans Affairs
Collaborators
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00857831
Brief Title
Vitamin D and Calcium Study
Official Title
Vitamin D and Calcium Replacement/Supplementation in Subjects With Chronic Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Kessler Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, Vitamin D deficiency, Functional Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Vitamin D & Calcium supplementation in FES
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D and Calcium
Intervention Description
2000 IU/day Vitamin D3 (cholecalciferol) and 1.3 g/day calcium carbonate will be taken for 15-20 weeks.
Primary Outcome Measure Information:
Title
Effects of Vitamin D and Calcium supplements on calcium metabolism and vitamin D deficiency
Time Frame
15-20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Bauman, MD
Organizational Affiliation
VA Medical Center, Bronx
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

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Vitamin D and Calcium Study

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