Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia

Evaluation of the Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Iron Deficiency Anemia During Pregnancy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: Intravenous iron sucrose; Drug: Lactoferrin

Detailed Description

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.

The study will include 100 pregnant women with moderate iron deficiency anemia. They will assigned randomly in to 2 groups. Each group will contain 50 patients.

The first group will receive intravenous iron sucrose (sacrofer 100mg/5ml)as 200 mg elemental iron in 100 ml 0.9 NaCl over 20-30 minutes up to the total dose -Total dose will be calculated from this equation=weight(kg)x(target Hb in g/dl-actual Hb in g/dl)x2.4+500 rounded up to the nearest multiple of 100 mg The second group will receive lactoferrin 100 mg twice daily orally before breakfast and before dinner (pravotin 100 mg sachets will be dissolved in ¼ glass of water). Patients will be advised to avoid coffee, milk products and antacid before and after the dose of lactoferrin.

1. Baseline assessment:

All women in the study will be submitted to:

1. Complete History Taking Including:

   • Personal history: This included name, age, duration of marriage, last menstrual period, parity, occupation and special habits.
   • 1st day of last menstrual period.
   • Estimated gestational age
   • Contraceptive history
   • Obstetric history Including:
   • Full details of previous pregnancies (Date, outcome, onset and mode of delivery, gestational age at delivery and any associated complication or history of similar disorder, spacing between each pregnancy.
2. General Examination Included: Weight, height, body Mass Index (BMI), temperature, pulse, blood pressure, chest and cardiac examination, signs of anemia
3. Abdominal Examination
4. Fetal monitoring: To confirm fetal maturity and fetal wellbeing by non-stress test and biophysical profile.
5. U/S investigation: To confirm gestational age and exclude associated congenital anomalies.

Investigations:

• Complete blood sample (CBC), total iron binding capacity and Transferrin saturation will be done in Ain Shams Maternity Hospital Labs.
• Serum ferritin will be sent to any private lab.

• Kidney function tests and liver function tests. 2. Follow up assessment:

  • Anemic pregnant women will be followed up every 4 weeks until delivery.

  • In between visits, patients will be contacted via phone for monitoring of any side effects.

    3. End of study assessment:

• the same laboratory tests will be done with monitoring of any signs or symptoms of anemia until Hb level > 11 g/dl

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amal Elkholy, PhD; Phone Number: +201060355448; Email: amalanas9@gmail.com
• Study Contact Backup: Name: Lina EL-Saeed, master; Phone Number: +201092554407; Email: linanabil1990@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:-

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous Iron Sucrose group; 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; 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; Other Names: Intravenous iron sucrose(Sacrofer 100mg/5ml) was manufactured by Amoun company for pharmaceutical and chemical industry ,Egypt.
Active Comparator: Lactoferrin group; 50 pregnant women will receive lactoferrin 100 twice daily orally .	Drug: Lactoferrin; 100 mg twice daily orally before breakfast and dinner; Other Names: lactoferrin 100 mg (Pravotin100 mg sachet)was manufactured by Hygint company for pharmaceutical and chemical industry,Egypt. Egypt) twice daily orally .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of lactoferrin side effect	assessment of the incidence rate of nausea, vomiting and GIT upset	4 weeks
the incidence rate of constipation		4 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Nagwa Sabri, professor, Department of Clinical Pharmacy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Lactoferrin; Anemia in pregnancy; Iron Sucrose
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies; Physiological Effects of Drugs; Anti-Infective Agents; Trace Elements; Micronutrients; Hematinics; Iron; Ferric Oxide, Saccharated; Lactoferrin
• Other Study ID Numbers: Lactoferrin in Anemia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No