NCT03940430

Brief Summary

This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2018

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 10, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

April 12, 2019

Last Update Submit

May 27, 2020

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Management of iron deficiency anemia incidence by using lab measures include iron profile

    Management of iron deficiency anemia

    One month

Study Arms (3)

Lactoferrin in iron deficiency anemia

ACTIVE COMPARATOR

lactoferrin ( pravotin) 100mg twice daily

Drug: Lactoferrin

Ferrous sulfate in iron deficiency anemia

ACTIVE COMPARATOR

ferrous sulphate (hemojet)

Drug: Ferrous sulfate

Lactoferrin and ferrous sulfate in iron deficiency anemia

ACTIVE COMPARATOR

Lactoferrin 100 mg twice daily and ferrous sulfate

Drug: LactoferrinDrug: Ferrous sulfate

Interventions

LactoferrinDRUG

This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

Lactoferrin and ferrous sulfate in iron deficiency anemiaLactoferrin in iron deficiency anemia
Ferrous sulfateDRUG

This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

Also known as: ferrous sulphate
Ferrous sulfate in iron deficiency anemiaLactoferrin and ferrous sulfate in iron deficiency anemia

Eligibility Criteria

Age19 Years - 29 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female student with iron deficiency anemia

You may not qualify if:

  • clinical diagnosis of chronic disease as DM, Malabsorption disease Celiac, blood disease as thalassemia, or haemoglobinopathy
  • Intervention:
  • Study participants will be divided into 3 groups; Group 1: 35 participants will be supplemented with iron salt 324 mg (66 mg of elemental iron) orally three time per day before meal for one month Group 2: 35 participants will be supplemented with LF sachet 100 mg twice per day before meal for period of one month.
  • Group 3: 35 participants will be supplemented with combined iron salt 324 mg (66 mg of elemental iron) orally three time per day before meal for one month, and LF sachet 100 mg twice per day before meal for period of one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 202, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Lactoferrinferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteins

Study Officials

  • Yasmin G Elgendy, M.d

    Ainshams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Yasmin gamel elgendy clinical professor

Study Record Dates

First Submitted

April 12, 2019

First Posted

May 7, 2019

Study Start

September 10, 2018

Primary Completion

November 10, 2018

Study Completion

January 10, 2019

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)