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Vitamin D and Calcium Study

This study has been completed.
Kessler Foundation
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: March 5, 2009
Last updated: October 2, 2012
Last verified: October 2012
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: 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.


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

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
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Please refer to this study by its identifier: NCT00857831

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
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT00857831     History of Changes
Other Study ID Numbers: B4162C-8
Study First Received: March 5, 2009
Last Updated: October 2, 2012

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

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Vitamin D
Calcium, Dietary
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 23, 2017