Lactoferrin Alone ,Iron Alone Vs Lactoferrin Plus Iron for Treatment of Iron Deficiency Anemia

NCT06590831 | Completed DMC

• 1 other identifier: Rehab Ahmed Amine
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency (ID) and iron deficiency anemia (IDA) are the most common iron disorders throughout the world. ID and IDA, particularly caused by increased iron requirements during pregnancy; represent a high risk for preterm delivery, fetal growth retardation, low birth weight, and inferior neonatal health. These pregnancy complications are thought to occur because of an increased iron requirement, related to enhanced blood volume and development of the fetoplacental unit.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Treatment of Anemia

  Efficacy of lactoferrin alone and lactoferrin with iron for treatment of iron deficiency anemia during 3rd trimester of pregnancy by measuring the hemoglobin level before and after treatment

  6 months

Study Arms (3)

Group A: (lactoferrin Group)

ACTIVE COMPARATOR

About 133 anemic pregnant women will be treated with lactoferrin only (pravotin 100mg ) twice daily for 4 weeks.

Drug: Lactoferrin

Group B: (Amino acid chelated iron Group)

ACTIVE COMPARATOR

About 133 anemic pregnant women will be treated with amino acid chelated iron only (phara fero 27) once daily for 4 weeks.

Drug: Lactoferrin

Group C: (lactoferrin with amino acid chelated iron Group)

ACTIVE COMPARATOR

About 133 anemic pregnant women will be treated with lactoferrin with amino acid chelated iron (phara fero 27 plus ) once daily for 4 weeks

Drug: Lactoferrin

Interventions

Lactoferrin DRUG

to compare between efficacy of lactoferrin alone and lactoferrin with iron for treatment of iron deficiency anemia during 3rd trimester of pregnancy

Also known as: Iron

Group A: (lactoferrin Group); Group B: (Amino acid chelated iron Group); Group C: (lactoferrin with amino acid chelated iron Group)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women with single fetus
• All pregnant women in 3rd trimester (28w\_36w) complaining of mild IDA
• Iron Deficiency Anemia mild anemia (hemoglobin level \< 11 mg/dl , and serum ferritin level \< 12 mg/dl).

You may not qualify if:

• Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia.
• Clinical and/or laboratory evidence of hepatic, renal, cardiovascular abnormalities.
• History of peptic disorders.
• Esophagitis
• Hiatal hernia
• Malabsorption syndrome

Sponsors & Collaborators

• Egymedicalpedia: lead
• Al-Azhar University: collaborator

Study Sites (1)

Al-Azhar University hospitals

Asyut, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Lactoferrin; Iron

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Ahmed Ali Nasr, Professor

  Al-Azhar University, Faculty of medicine, Assuit.

  STUDY CHAIR

• Medhat kamel fathy, Lecturer

  Al-Azhar University, Faculty of medicine, Assuit.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: June 10, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)