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

NCT06252103 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-09

No results posted yet for this study

Summary

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Women will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.

Conditions

  • Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia

Interventions

DRUG

Ferrous Gluconate 300 MG

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

DRUG

ferrous gluconate with lactoferrin

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • AMR Saad, doctoral · faculty of medicine Ain shams university

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
2023-05-30
Primary Completion
2023-11-30
Completion
2023-12-30

Countries

  • Egypt

Study Locations

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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 NCT06252103 on ClinicalTrials.gov