Vitamin D and Calcium Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00857831

Enrollment

Registered

2009-03-09

Start date

2008-01-31

Completion date

2012-08-31

Last updated

2012-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

spinal cord injury, Vitamin D deficiency, Functional Electrical Stimulation

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).

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Effects of Vitamin D and Calcium supplements on calcium metabolism and vitamin D deficiency	15-20 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026