A Phase 1/2 interventional study of Oral lactoferrin and TDI of LMW iron dextran in Iron Deficiency Anemia, sponsored by Woman's Health University Hospital, Egypt. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Woman's Health University Hospital, Egypt · Phase 1/2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.
Also known as: Oral Fizzing Lactoferrin
Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously
Also known as: Parental dextran
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
Time frame: 4- 8 weeks
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.
Time frame: 4-8 weeks
Plan to share: Yes — Publishing
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
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Woman's Health University Hospital, Egypt