Vitamine d Dosage and Constipation | NCT03096704

Studies
Vitamine d Dosage and Constipation

NCT03096704

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Status

Unknown status

Last Update Posted

Mar 31, 2017Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Vitamine d Dosage in Slow Transit Time Constipation

Interventions

vitamine d dosage

Countries

Italy

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2017Actual

Primary Completion Date

Apr 30, 2017Estimated

Completion Date

May 15, 2017Estimated

First Submitted Date

Mar 26, 2017

First Submission Date that Met QC Criteria

Mar 26, 2017

First Posted Date

Mar 30, 2017Actual

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

Mar 30, 2017

Last Update Posted Date

Mar 31, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

alba panarese, principal investigator, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Vitamine d dosage in important to define nutritional status and bone metabolism. For patients with intestinal disorders it is important to establish the intestinal absorptive function.

It is important to establish the absorption of vitamin D which correlate with different biological activity and bone metabolism, immune function and the communication between the cells.

Detailed Description

Constipation is a disease that involves poor intestinal functioning. The reduced intestinal motility slows down intestinal function. Up to make lower the dosage of vitamin D. Vitamin D helps many cellular activities and enhances the action of tissue,Its Your dosage allows you to evaluate the efficacy of intestinal function and to better understand its severity.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
slow transit time constipation			Diagnostic Test: vitamine d dosage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamine d dosage	Diagnostic Test	dosage of vitamine D in slow transit time constipation	slow transit time constipation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
dosage of vitamine D	dosage of vitamine d in slow transit time constipation	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

slow transit time constipation

Exclusion Criteria:

drugs assumption comorbidity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

observational prospective study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
alba panarese	Contact	3471401487		albapanarese@libero.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alba Panarese	Recruiting	Noci	Apulia	70015	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 31, 2020
Reset	Aug 14, 2020

Submission Tracking

Estimated Results First Submitted Date

Jul 31, 2020

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 31, 2020			Aug 14, 2020