Clinical trial

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

NCT05921968

Name

Lactoferrin in Anemia

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.

Trial arms

Trial start

2023-07-30

Estimated PCD

2024-01-01

Trial end

2024-04-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

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

Arms:

Intravenous Iron Sucrose group

Other names:

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

Lactoferrin

100 mg twice daily orally before breakfast and dinner

Arms:

Lactoferrin group

Other names:

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

Size

100

Primary endpoint

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

4 weeks

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

4 weeks

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective,randomized,open-label,parallel-group study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-07-19

1 organization

2 products

1 indication

Organization

Ain Shams University

Product

Iron Sucrose

Indication

Iron Deficiency Anemia

Product

Lactoferrin