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CompletedNCT00857831Updated Oct 3, 2012

Vitamin D and Calcium Study

An interventional study of Vitamin D and Calcium in Spinal Cord Injury, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-03.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Spinal Cord Injury

Keywords

  • spinal cord injury
  • Vitamin D deficiency
  • Functional Electrical Stimulation
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 10 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • History of kidney stones
  • History of bone disorders
  • Currently pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Arm 1

    Vitamin D \& Calcium supplementation in FES

    Dietary Supplement: Vitamin D and Calcium

Interventions

  • Dietary supplementVitamin D and Calcium

    2000 IU/day Vitamin D3 (cholecalciferol) and 1.3 g/day calcium carbonate will be taken for 15-20 weeks.

06

What researchers measure

Primary outcomes

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

    Time frame: 15-20 weeks

07

Study locations

1 site
  • VA Medical Center, Bronx
    Bronx, New York 10468, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00857831
Lead sponsor
US Department of Veterans Affairs
Collaborators
Kessler Foundation
Responsible party
Sponsor
First posted
Mar 9, 2009
Start date
Jan 2008
Primary completion
Jan 2012
Completion
Aug 2012
Last update
Oct 3, 2012

Study contacts

William Bauman, MD
principal investigator · VA Medical Center, Bronx

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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