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

Phase 1

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Combination Product: Oral lactoferrin; Combination Product: TDI of LMW iron dextran

• Registration Number: NCT03279536
• Lead Sponsor: Woman's Health University Hospital, Egypt

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.

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Study Start: 2017-11-01
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Lactoferrin	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
Total dose infusion (TDI) iron dextran	TDI of LMW 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

Primary Outcome Measures

Name	Time	Method
the change in Hb concentration	4- 8 weeks	measure the change in Hb concentration from baseline to week 4 after oral Lactoferrin treatment and relieve of symptoms of anemia

Secondary Outcome Measures

Name	Time	Method
measure the change in serum iron, serum ferritin	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.

Trial Locations

Locations (1)

Women Health Hospital; 🇪🇬 Asyut, Egypt