NCT03456258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
Last Updated

March 7, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

February 23, 2018

Last Update Submit

February 28, 2018

Conditions

Iron Deficiency Anemia of Pregnancy

Outcome Measures

Primary Outcomes (1)

  • hemoglobin level

    Measure hemoglobin level two months after treatment

    2 months

Secondary Outcomes (1)

  • Serum ferritin

    2 months

Study Arms (2)

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

Complete blood countDIAGNOSTIC_TEST

To measure hemoglobin difference and serum ferritin levels .

Also known as: Serum ferritin
Ferrous sulphateLactoferrin

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams maternity hospital

Cairo, Abbasia, 11591, Egypt

Location

MeSH Terms

Interventions

Blood Cell Count

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Ahmed M Ragab, MBBCH

    Ainshams university maternity hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 7, 2018

Study Start

September 5, 2017

Primary Completion

December 10, 2017

Study Completion

January 15, 2018

Last Updated

March 7, 2018

Record last verified: 2018-02

Locations

EG(1)