Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia

NCT05921968 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-19

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

Lactoferrin

100 mg twice daily orally before breakfast and dinner

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Nagwa Sabri, professor · Department of Clinical Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-30
Primary Completion
2024-01-01
Completion
2024-04-01

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05921968 on ClinicalTrials.gov