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Completed

NCT Number: NCT03279536

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Women Health Hospital

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral lactoferrin

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.

Other names: Oral Fizzing Lactoferrin

TDI of LMW iron dextran

Combination Product

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

Other names: Parental dextran

Primary outcomes

  1. the change in Hb concentration

    Time frame: 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 outcomes

  1. measure the change in serum iron, serum ferritin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Woman's Health University Hospital, Egypt

Other

Registry information

Acronym: TDI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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