Impact of Work Environment Absent of Natural Light on Vit... | NCT01385085

Studies
Impact of Work Environment Absent of Natural Light on Vitamin D Levels

NCT01385085

Sponsor

Medical Corps, Israel Defense Force

Status

Unknown status

Last Update Posted

Jun 29, 2011Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Vitamin D Deficiency

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 28, 2011

First Submission Date that Met QC Criteria

Jun 28, 2011

First Posted Date

Jun 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2011

Last Update Posted Date

Jun 29, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Three types of workers exposed to different levels of natural sunlight will be tested for Vitamin D blood level, PTH, Ca, P, albumin and alkaline phosphatase.

In addition, each tested worker will be asked to fill a questionnaire for demographic, medical and personal habit information.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No natural sunlight		one group works in a basement with no natural sunlight
Low level of Natural Sunlight		the second group work in offices with unopenable windows.
High level of Natural Sunlight		The third group works outdoors.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

people employed in their current work place at least 6 months,

Exclusion Criteria:

people who consume food additives containing Vitamin D.
people who have a chronic illness which harms the Vitamin D absorption, such as Celiac, chronic Pancreatitis, Cystic Fibrosis and IBS.
people who have a chronic illness which harms Vitamin D metabolism, such as chronic hepatitis, kidney insufficiency and Nephrotic Syndrome.
pregnant women.
people who require prescribed medicine like steroids, anti-convulsion, and HIV treatments.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

People employed in three types of natural sunlight exposure.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided