Vitamin D and Calcium Study

October 2, 2012 updated by: US Department of Veterans Affairs

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10468
        • VA Medical Center, Bronx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (ESTIMATE)

March 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4162C-8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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