Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing (TDI)

October 23, 2020 updated by: Howieda Fouly, Woman's Health University Hospital, Egypt
This study consisted of 60 cases. All the cases of pregnant women are 4 months to 8 months of pregnancy. The cases divided into 30 pregnant women's were given iron supplementation without health education and another 30 were given iron supplementation and health education for comparison between them. Comparative between hemoglobin levels before and after medication. Treatment of iron deficiency anemia with iron supplementation received for one month.

Study Overview

Detailed Description

The investigator will divide the participants into two groups e.g. group (A) and group (B) according to Hemoglobin level and receiving of oral supplementation for IDA accompanied with health education in case of group (A) and without health education in case of group (B). Then the investigator asked patient to sign the document of her investigations result to receive iron supplementation.

  • After that, the investigator observes hemoglobin's Level, when it less than >11g/dl, the patient will be the group (A) who will receive oral iron supplementation and health education.
  • Group (B) who will receive Total Dose Infusion (TDI) without health education.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Asyut, Egypt, 71111
        • Women Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Pregnant Women aged >18 years
  2. Hemoglobin<10g/dl
  3. Gestational age between 14-28 weeks
  4. Singleton pregnancy
  5. Willingness to participate and signing the informed consent form

Exclusion Criteria:

  1. Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia),
  2. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis).
  3. Decompensated liver cirrhosis and active hepatitis (ALAT>3 times upper limit of normal).
  4. Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP).
  5. Rheumatoid arthritis with symptoms or signs of active inflammation.
  6. Multiple allergies.
  7. Known hypersensitivity to parental iron or any recipients in the investigational drug products.
  8. Erythropoietin treatment within 8 weeks prior to the screening visit.
  9. Other iron treatment within 8 weeks prior to the screening visit.
  10. Planned elective surgery during the study.
  11. Participation in any other clinical within 3 months prior to the screening.
  12. Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Lactoferrin
Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks
Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.
Other Names:
  • Oral Fizzing Lactoferrin
Active Comparator: Total dose infusion (TDI) iron dextran
Group B is a parenteral total dose infusion (TDI) of LMW iron dextran 20mg/kg body weight for 4 weeks Intervention: The participants 33 will receive parental iron 20mg/kg body weight for 4 weeks
Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously
Other Names:
  • Parental dextran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in Hb concentration
Time Frame: 4- 8 weeks
measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia
4- 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure the change in serum iron, serum ferritin
Time Frame: 4-8 weeks
measure the change in serum iron, serum ferritin based on comparison between oral lactoferrin with health education & TDI from hospital routine care.
4-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Warda Helmy, BSN, WHH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publishing

IPD Sharing Time Frame

3-6 months

IPD Sharing Access Criteria

Introduction, Methodology, data analysis, Findings, Discussion & Conclusion

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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