Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05921968

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia	Drug: Intravenous iron sucrose Drug: Lactoferrin	Phase 4

Detailed Description

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.

Baseline assessment:

All women in the study will be submitted to:

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.

General Examination Included: Weight, height, body Mass Index (BMI), temperature, pulse, blood pressure, chest and cardiac examination, signs of anemia
Abdominal Examination
Fetal monitoring: To confirm fetal maturity and fetal wellbeing by non-stress test and biophysical profile.
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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective,randomized,open-label,parallel-group studyprospective,randomized,open-label,parallel-group study

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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 .

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 .

Outcome Measures

Primary Outcome Measures

evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of ferritin [4 weeks]
estimation serum ferritin level
evaluate the effect of oral lactoferrin as compared to intravenous iron sucrose on the serum level of hemoglobin [4 weeks]
estimation hemoglobin level

Secondary Outcome Measures

evaluation of lactoferrin side effect [4 weeks]
assessment of the incidence rate of nausea, vomiting and GIT upset
the incidence rate of constipation [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.