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

Woman's Health University Hospital, Egypt

Status and phase: Completed; Phase 2; Phase 1

Conditions: Iron Deficiency Anemia

Treatments: Combination Product: Oral lactoferrin; Combination Product: TDI of LMW iron dextran

Study type: Interventional

Funder types: Other

Identifiers

NCT03279536

WHH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

99 participants in 2 patient groups

Oral Lactoferrin

Experimental group

Description:

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

Treatment:

Combination Product: Oral lactoferrin

Total dose infusion (TDI) iron dextran

Active Comparator group

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

Treatment:

Combination Product: TDI of LMW iron dextran