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Vitamin D and Calcium Study

NCT ID: NCT00857831

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Spinal Cord Injury

Keywords

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spinal cord injury Vitamin D deficiency Functional Electrical Stimulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Vitamin D \& Calcium supplementation in FES

Group Type EXPERIMENTAL

Vitamin D and Calcium

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin D and Calcium

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kessler Foundation

OTHER

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Bauman, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Bronx

Locations

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VA Medical Center, Bronx

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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B4162C-8

Identifier Type: -

Identifier Source: org_study_id