Vitamin D Estimation With Giardia Lamblia Infections | NCT04778280

Studies
Vitamin D Estimation With Giardia Lamblia Infections

NCT04778280

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Mar 3, 2021Actual

Enrollment

192Estimated

Phase

Not provided

Conditions

Giardia Lamblia Infection

Interventions

Not provided

Countries

Egypt

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

Feb 2021

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

Feb 17, 2021Actual

Primary Completion Date

Feb 2022Estimated

Completion Date

Feb 2022Estimated

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Feb 27, 2021

First Posted Date

Mar 3, 2021Actual

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

Feb 27, 2021

Last Update Posted Date

Mar 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

investigators will take stool and blood samples from two groups of humans :-

1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections

Detailed Description

In this research a case- control study will be used) ,the percentage of case to control will be 1:1 the total number of samples 192 ,investigators will take stool and blood samples from two groups of humans :-

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

192Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		1-Group A(Healty group with negative Giardia lamblia or control group) 96 samples
Group B		2- Group B(Cases group with positive Giardia lamblia )96 sample

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fluctuation level of vitamin D level	Estimation of vitamin D level in humans infected with Giardia lamblia	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient infected with Giardia lamblia.

Exclusion Criteria:

patient takes vitamin D supplement - patient has kidney disease- patient has liver disease-patient has a debilitating disease disease such as cancer or diabetes.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

we take 192 samples then we will divide these samples into two groups :-

Group A (healty group with negative Giardia lamblia or control group)
Group B ( diseased group with positive Giardia lamblia or cases group)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammed Sayed Farrag, Demonstrator	Contact	01110054887		mohameds_post@med.sohag.edu.eg
Noha Sammer Ahmed, Assist prof	Contact	01273126001

Overall Officials

Name	Affiliation	Role
Mohammed Sayed Farrag, Demonstrator	faculty of medicine sohag university	Principal Investigator
Mohammed Sayed Farrag, Demonstrator	faculty of medicine sohag university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Sohag University	Recruiting	Sohag			Egypt

Type	Date	Date Unknown
Release	Feb 12, 2023
Reset	Dec 4, 2023

Submission Tracking

Estimated Results First Submitted Date

Feb 12, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 12, 2023			Dec 4, 2023

Condition Browse Module

MeSH Terms

ID	Term
D005873	Giardiasis

Ancestor Terms

ID	Term
D007411	Intestinal Diseases, Parasitic
D010272	Parasitic Diseases
D007239	Infections
D011528	Protozoan Infections

Browse Leaves

Not provided

Browse Branches

Not provided