Vitamin D and Calcium Study

Spinal Cord Injury Clinical Trial

Official title:

Vitamin D and Calcium Replacement/Supplementation in Subjects With Chronic Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857831
• Other study ID #: B4162C-8
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: October 2, 2012
• Start date: January 2008
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Vitamin D and Calcium supplements on calcium metabolism and vitamin D deficiency		15-20 weeks	No