Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia

NCT ID: NCT05921968

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2024-04-01

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.

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

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Intravenous iron sucrose

Intervention Type: 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

Lactoferrin group

50 pregnant women will receive lactoferrin 100 twice daily orally .

Group Type: ACTIVE_COMPARATOR

Lactoferrin

Intervention Type: DRUG

100 mg twice daily orally before breakfast and dinner

Interventions

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

Intervention Type: DRUG

Lactoferrin

100 mg twice daily orally before breakfast and dinner

Intervention Type: DRUG

Other Intervention Names

Intravenous iron sucrose(Sacrofer 100mg/5ml) was manufactured by Amoun company for pharmaceutical and chemical industry ,Egypt.; lactoferrin 100 mg (Pravotin100 mg sachet)was manufactured by Hygint company for pharmaceutical and chemical industry,Egypt. Egypt) twice daily orally .

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Amal A. Elkholy

lecturer of clinical pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagwa Sabri, professor

Role: STUDY_CHAIR

Department of Clinical Pharmacy

Central Contacts

Amal Elkholy, PhD

Role: CONTACT

amalanas9@gmail.com

+201060355448

Lina EL-Saeed, master

Role: CONTACT

linanabil1990@gmail.com

+201092554407

References

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.

Reference Type: BACKGROUND

PMID: 34440102 (View on PubMed)

Other Identifiers

Lactoferrin in Anemia

Identifier Type: -

Identifier Source: org_study_id