NCT00857831

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

4 years

First QC Date

March 5, 2009

Last Update Submit

October 2, 2012

Conditions

Spinal Cord Injury

Keywords

spinal cord injuryVitamin D deficiencyFunctional Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

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

    15-20 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Vitamin D \& Calcium supplementation in FES

Dietary Supplement: Vitamin D and Calcium

Interventions

Vitamin D and CalciumDIETARY_SUPPLEMENT

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

Arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesVitamin D Deficiency

Interventions

Vitamin DCalcium

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • William Bauman, MD

    VA Medical Center, Bronx

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 9, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

August 1, 2012

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations

US(1)