NCT03481790

Brief Summary

This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy. Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_2

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 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

March 12, 2018

Last Update Submit

March 22, 2018

Conditions

Iron Deficiency Anemia of Pregnancy

Keywords

iron deficiency anemia of pregnancy - lactoferrin

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin (Hb) level.

    to be measured before and after treatment.

    4 weeks

Secondary Outcomes (1)

  • serum ferritin level.

    4 weeks

Study Arms (2)

Lactoferrin

EXPERIMENTAL

100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.

Drug: Lactoferrin

ferrous sulphate + folic acid (vitamin B9)

EXPERIMENTAL

150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.

Drug: ferrous sulphate + folic acid (vitamin B9)

Interventions

LactoferrinDRUG

(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.

Also known as: Pravotin, MamyVital
Lactoferrin
ferrous sulphate + folic acid (vitamin B9)DRUG

(Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks.

Also known as: Ferrofol
ferrous sulphate + folic acid (vitamin B9)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with single fetus
  • Hb count \< 11g/dL
  • ferritin level \< 12 ng/dL
  • Gestational age (14 - 30 weeks)

You may not qualify if:

  • Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
  • Associated bleeding disorder
  • Anaemia requiring blood tranfusion (Hb \< 7g/dL)
  • Hypersensitivity to iron preparations
  • Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Lactoferrinferrous sulfateFolic Acid

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteinsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ahmed Mamdouh

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 29, 2018

Study Start

September 1, 2017

Primary Completion

March 5, 2018

Study Completion

March 5, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)