Lactoferrin Versus Ferrous Sulphate for the Treatment of... | NCT03456258

Studies
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy

NCT03456258

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Mar 7, 2018Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Iron Deficiency Anemia of Pregnancy

Interventions

Complete blood count

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

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2017Actual

Primary Completion Date

Dec 10, 2017Actual

Completion Date

Jan 15, 2018Actual

First Submitted Date

Feb 23, 2018

First Submission Date that Met QC Criteria

Feb 28, 2018

First Posted Date

Mar 7, 2018Actual

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 28, 2018

Last Update Posted Date

Mar 7, 2018Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.

Detailed Description

The study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups .

Group one lactoferrin group Group two ferrous sulphate group

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactoferrin	Experimental	To measure hemoglobin difference and serum ferritin	Diagnostic Test: Complete blood count
Ferrous sulphate	Experimental	To measure hemoglobin difference and serum ferritin	Diagnostic Test: Complete blood count

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Complete blood count	Diagnostic Test	To measure hemoglobin difference and serum ferritin levels .	Ferrous sulphate Lactoferrin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hemoglobin level	Measure hemoglobin level two months after treatment	2 months

Secondary Outcomes

Measure	Description	Time Frame
Serum ferritin	Measure serum ferritin level	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women from 20 to 40 years
iron deficiency anemia (mild and moderate)
gestational age 13 to 26 weeks
singleton viable pregnancy.

Exclusion Criteria:

history of anemia due to chronic blood loss
hemolytic anemia
severe anemia
history of peptic ulcer

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed M Ragab, MBBCH	Ainshams university maternity hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ainshams maternity hospital		Cairo	Abbasia	11591	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D001772	Blood Cell Count

Ancestor Terms

ID	Term
D002452	Cell Count
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided