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

Iron Deficiency Anemia Clinical Trial

— TDI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279536
• Other study ID #: WHH
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: October 2020
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Combination Product:
• 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.
• TDI of LMW iron dextran
Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously

Locations

Country	Name	City	State
Egypt	Women Health Hospital	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4- 8 weeks
Secondary	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.	4-8 weeks