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

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Oral lactoferrin

TDI of LMW iron dextran

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Women Health Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral Lactoferrin

Total dose infusion (TDI) iron dextran

Arm Description

Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks

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

Outcomes

Primary Outcome Measures

the change in Hb concentration

measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia

Secondary Outcome Measures

measure the change in serum iron, serum ferritin

measure the change in serum iron, serum ferritin based on comparison between oral lactoferrin with health education & TDI from hospital routine care.

Full Information

NCT ID

NCT03279536

First Posted

August 30, 2017

Last Updated

October 23, 2020

Sponsor

Woman's Health University Hospital, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT03279536

Brief Title

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

Acronym

TDI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

December 30, 2018 (Actual)

Study Completion Date

December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Woman's Health University Hospital, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Group A will receive oral lactoferrin & group B will receive Total dose infusion

Masking

Participant

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Lactoferrin

Arm Type

Experimental

Arm Description

Group A is 120 mg of Oral lactoferrin for 4 weeks Intervention: The participants 66 will receive oral Lactoferrin 120mg for 4 weeks

Arm Title

Total dose infusion (TDI) iron dextran

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

Oral lactoferrin

Other Intervention Name(s)

Oral Fizzing Lactoferrin

Intervention Description

Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.

Intervention Type

Combination Product

Intervention Name(s)

TDI of LMW iron dextran

Other Intervention Name(s)

Parental dextran

Intervention Description

Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously

Primary Outcome Measure Information:

Title

the change in Hb concentration

Description

measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia

Time Frame

4- 8 weeks

Secondary Outcome Measure Information:

Title

measure the change in serum iron, serum ferritin

Description

measure the change in serum iron, serum ferritin based on comparison between oral lactoferrin with health education & TDI from hospital routine care.

Time Frame

4-8 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnant female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant Women aged >18 years Hemoglobin<10g/dl Gestational age between 14-28 weeks Singleton pregnancy Willingness to participate and signing the informed consent form Exclusion Criteria: Anemia predominantly caused by factors other than IDA (e.g. anemia with untreated B12 or foliate deficiency, hemolytic anemia), Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and haemosidrosis). Decompensated liver cirrhosis and active hepatitis (ALAT>3 times upper limit of normal). Active acute or chronic infections (assessed by clinical judgment supplied with white Blood Cells (WBC) and C - reactive protein (CRP). Rheumatoid arthritis with symptoms or signs of active inflammation. Multiple allergies. Known hypersensitivity to parental iron or any recipients in the investigational drug products. Erythropoietin treatment within 8 weeks prior to the screening visit. Other iron treatment within 8 weeks prior to the screening visit. Planned elective surgery during the study. Participation in any other clinical within 3 months prior to the screening. Any other medical condition e.g. malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Warda Helmy, BSN

Organizational Affiliation

WHH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women Health Hospital

City

Asyut

ZIP/Postal Code

71111

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Publishing

IPD Sharing Time Frame

3-6 months

IPD Sharing Access Criteria

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

Learn more about this trial

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

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