Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia

NCT05921968 | Unknown Phase 4

• 1 other identifier: Lactoferrin in Anemia
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Iron deficiency is the most common nutritional deficiency and the most common cause of anemia. Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis. The study aims to compare the effect of Lactoferrin versus intravenous iron sucrose for the treatment of iron deficiency anemia during pregnancy.

Conditions

Iron Deficiency Anemia

Keywords

Anemia in pregnancy; Lactoferrin; Iron Sucrose

Outcome Measures

Primary Outcomes (2)

• evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of ferritin

  estimation serum ferritin level

  4 weeks

• evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of hemoglobin

  estimation hemoglobin level

  4 weeks

Secondary Outcomes (2)

• evaluation of lactoferrin side effect

  4 weeks

• the incidence rate of constipation

  4 weeks

Study Arms (2)

Intravenous Iron Sucrose group

ACTIVE COMPARATOR

50 pregnant women will receive 200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose -The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\\dL - actual Hb in g\\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg

Drug: Intravenous iron sucrose

Lactoferrin group

ACTIVE COMPARATOR

50 pregnant women will receive lactoferrin 100 twice daily orally .

Drug: Lactoferrin

Interventions

Intravenous iron sucrose DRUG

200 mg elemental iron in 100 ml 0.9 NaCl intravenous over 20 -30 minutes daily up to the total dose) o The dose of the total iron sucrose to be administrated was calculated from the following formula: Total dose required = weight (kg) x (target Hb in g\\dL - actual Hb in g\\dL) x 2.4 + 500 mg rounded up to the nearest multiple of 100 mg

Also known as: Intravenous iron sucrose(Sacrofer 100mg/5ml) was manufactured by Amoun company for pharmaceutical and chemical industry ,Egypt.

Intravenous Iron Sucrose group

Lactoferrin DRUG

100 mg twice daily orally before breakfast and dinner

Also known as: lactoferrin 100 mg (Pravotin100 mg sachet)was manufactured by Hygint company for pharmaceutical and chemical industry,Egypt. Egypt) twice daily orally .

Lactoferrin group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women with iron deficiency anemia.
• Microcytic hypochromic anemia, moderate anemia (Hb 8 to 9.9 g/dl) and S. Ferritin levels \<12 ng/dl as per WHO guidelines
• Gestational age: - 13-26 weeks.
• Singleton viable pregnancy
• Lastly, agreement to participate and sign the informed consent was a basic prerequisite

You may not qualify if:

• Women with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemia trait).
• Severe anemia \<7 g/dl requiring blood transfusion, bronchial asthma, clinical and/or laboratory evidence of hepatic, renal, hematologic or cardiovascular abnormalities.
• History of peptic ulcer.
• Hypersensitivity to iron preparations and treatment with any other iron preparation in the last one month before study entry.
• Suspected acute infection.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• Artym J, Zimecki M, Kruzel ML. Lactoferrin for Prevention and Treatment of Anemia and Inflammation in Pregnant Women: A Comprehensive Review. Biomedicines. 2021 Jul 27;9(8):898. doi: 10.3390/biomedicines9080898.

  PMID: 34440102 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Pharmaceutical Preparations; Lactoferrin; Chemical Industry

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; Manufacturing Industry; Industry; Technology, Industry, and Agriculture

Study Officials

• Nagwa Sabri, professor

  Department of Clinical Pharmacy

  STUDY CHAIR

Central Study Contacts

Amal Elkholy, PhD

CONTACT

+201060355448; amalanas9@gmail.com

Lina EL-Saeed, master

CONTACT

+201092554407; linanabil1990@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 100 opaque envelopes will be numbered serially and the corresponding letter which denotes the allocation will be put according to the electronic randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the envelope will be opened and the patient will be allocated according to the letter inside
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of clinical pharmacy

Model Details: prospective,randomized,open-label,parallel-group study

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: July 30, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share