Clinical trial NCT05921968: Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia
Official title: Evaluation of the Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Iron Deficiency Anemia During Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Keywords: Anemia in pregnancy
Lactoferrin
Iron Sucrose
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective,randomized,open-label,parallel-group study
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of ferritin
timeFrame: 4 weeks
measure: evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of hemoglobin
timeFrame: 4 weeks
Secondary outcomes:
measure: evaluation of lactoferrin side effect
timeFrame: 4 weeks
measure: the incidence rate of constipation
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Clinical Pharmacy
name: Nagwa Sabri, professor
role: STUDY_CHAIR
References:
citation: 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.