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Completed

NCT Number: NCT06252103

Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy

Study Procedures:

All patients will undergo the following:

Informed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.

1. History taking:

* Personal history: name, age, occupation and address. * Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration. * Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin. 2. Medical examination:

* General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill) * Abdominal examination to assess fundal height. 3. Investigations to perform will include:

Laboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.

Women will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.

Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain shams university maternity hospital

Cairo, 6825344, Egypt

About this study

This study included two groups:

Group I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.

Group II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.

hematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • The study will include women with the following inclusion and exclusion criteria:

Inclusion criteria

  • Pregnant women with single fetus
  • Microcytic hypochromic anemia, mild anemia Hb 10 to 10.5 g/dl) and moderate anemia (Hb 7 to 9.9 g/dl)
  • Gestational age (14 - 35 weeks)
  • Serum ferritin level <24 ng/dl

Exclusion criteria

  • Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
  • Associated bleeding disorder
  • Anaemia requiring blood tranfusion (Hb < 7gm/dL)
  • Hypersensitivity to iron preparations
  • Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)

Treatment and study plan

Ferrous Gluconate 300 MG

Drug

iron salt one tab 300 mg contain 35 mg of elemental iron given 2 doses 600 mg per day

Other names: (Ferrous-Gluconate®, tab.300mg glucofer, Egypt

ferrous gluconate with lactoferrin

Drug

Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids,Lactoferrin is a protein found in cow milk and human milk

Other names: Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.

Primary outcomes

  1. • Hemoglobin (Hb) level

    Time frame: 4 weeks

    hemoglobin will be measured before and after treatment by 4 weeks (HB in gm/dl)

  2. serum ferritin

    Time frame: 4 weeks

    serum ferritin will be measured before and after treatment by 4 weeks (ferritin in ug/l )

Secondary outcomes

  1. gastrointestinal side effects

    Time frame: 4 weeks

    (nausea , vomiting , constipation ) will be assessed before and after treatment

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.