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

NCT ID: NCT03279536

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A will receive oral lactoferrin \& group B will receive Total dose infusion
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Oral lactoferrin

Intervention Type COMBINATION_PRODUCT

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

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

Group Type ACTIVE_COMPARATOR

TDI of LMW iron dextran

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Oral lactoferrin

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

TDI of LMW iron dextran

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Oral Fizzing Lactoferrin Parental dextran

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Howieda Fouly

PhD of Obstetric & Gynecologic Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Warda Helmy, BSN

Role: PRINCIPAL_INVESTIGATOR

WHH

Locations

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Women Health Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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WHH

Identifier Type: -

Identifier Source: org_study_id