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Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students

Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03940430
Enrollment
90
Registered
2019-05-07
Start date
2018-09-10
Completion date
2019-01-10
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

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.

Detailed description

Iron, an essential element for cell growth and proliferation, is a component of fundamental processes such as DNA replication and energy production. However, iron can also be toxic when present in excess for its capacity to donate electrons to oxygen, thus causing the generation of reactive oxygen species (ROS), such as superoxide anions and hydroxyl radicals Prevalence of iron deficiency anemia is roughly 38% of pregnant women, 29% of non-pregnant women and 29% of all women of reproductive age have anemia globally Human lactoferrin (hLf), an 80-kDa multifunctional iron-binding cationic glycoprotein, is constitutively secreted by exocrine glands and by neutrophils during inflammation. hLf is recognized as a key element in the host immune defense system Bovine Lf (bLf), which shares high sequence homology with the human protein, is also a multifunctional glycoprotein with identical antibacterial, antifungal, antiviral, antiparasitic, anti-inflammatory, and immunomodulatory activities of hLf Lactoferrin is synthesized by exocrine glands and neutrophils under conditions of inflammation and at site of infection through its iron binding and formation of reactive oxygen species physiological transport of iron from tissue to circulation, thus curing iron deficiency and iron deficiency anemia A study done for pregnant women showed an increase of total serum iron in all bovin lactoferrin treated women. Therefore, the investigators speculated that bLf efficacy in curing AI was presumably not linked to direct iron supplementation, but to a more complex mechanism involving this protein in iron homeostasis Lactoferrin was also proven useful for prevention of iron deficiency anemia special among female long distance runner Lactoferrin was more effective than ferrous sulphate over a two months period in pregnant women with iron deficient anemia Aim of the Work 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.

Interventions

DRUGLactoferrin

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.

DRUGFerrous sulfate

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.

Sponsors

yasmin gamal el gendy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 29 Years
Healthy volunteers
No

Inclusion criteria

* female student with iron deficiency anemia

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Management of iron deficiency anemia incidence by using lab measures include iron profileOne monthManagement of iron deficiency anemia

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026