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

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ClinicalTrials.gov Identifier: NCT03279536
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Howieda Fouly, 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Combination Product: Oral lactoferrin Combination Product: TDI of LMW iron dextran Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A will receive oral lactoferrin & group B will receive Total dose infusion
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: 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
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.
Other Name: Oral Fizzing Lactoferrin

Active Comparator: 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
Combination Product: TDI of LMW iron dextran
Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously
Other Name: Parental dextran




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279536


Contacts
Contact: Howieda Fouly, PhD 1011993216 ext 101 hoida.elfouly@aun.edu.eg
Contact: Atef Darwish, Professor 01001572723 atef_darwish@yahoo.com

Locations
Egypt
Women Health Hospital Recruiting
Asyut, Egypt, 71111
Contact: Howieda A Fouly, Ph.D    1011993216    hoida.elfouly@aun.edu.eg   
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Principal Investigator: Warda Helmy, BSN WHH

Responsible Party: Howieda Fouly, PhD of Obstetric & Gynecologic Nursing, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT03279536     History of Changes
Other Study ID Numbers: WHH
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publishing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 3-6 months
Access Criteria: Introduction, Methodology, data analysis, Findings, Discussion & Conclusion

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Lactoferrin
Dextrans
Iron-Dextran Complex
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents
Anticoagulants
Plasma Substitutes
Blood Substitutes
Hematinics