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
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Combination Product: Oral lactoferrin Combination Product: TDI of LMW iron dextran||Phase 1 Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Group A will receive oral lactoferrin & group B will receive Total dose infusion|
|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|
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
- 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
- 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.
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
|Contact: Howieda Fouly, PhD||1011993216 ext firstname.lastname@example.org|
|Contact: Atef Darwish, Professoremail@example.com|
|Women Health Hospital||Recruiting|
|Asyut, Egypt, 71111|
|Contact: Howieda A Fouly, Ph.D 1011993216 firstname.lastname@example.org|
|Principal Investigator:||Warda Helmy, BSN||WHH|