Clinical trial NCT03202615: Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy
Official title: Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anemia During Pregnancy
Keywords: lactoferrin
iron deficiency anemia in pregnancy
Lead sponsor: Abdelwahed, Mai Mahmoud Mohamed, M.D.
Sponsor class: INDIV
First posted: 2017-06-28
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment period.

Detailed description: The study will includes130 pregnant women, from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt. Women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). Women will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, PCV, MCV, MCH, MCHC, Serum ferritin will be done at the start and the end of the treatment period.

Eligibility criteria: Inclusion Criteria:

* Pregnant with singleton intrauterine pregnancy
* 14- 20 weeks of gestation
* Have iron deficiency anemia (IDA) with hemoglobin 9 to less than 10.5 g/dl.

Exclusion Criteria:

* Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait).
* Hemoglobin less than 9 g/dL.
* Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities.
* History of acid-peptic disorders, esophagitis, or hiatal hernia.
* Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
* Medical disorders with pregnancy.
* Bleeding in early pregnancy.
* Allergies to milk proteins / hypersensitivity to iron preparations.
* History of ingestion of any hematinics within the last 1 month before study entry.
* Recent blood transfusion.
* Refusal to participate in the study.

Primary outcomes:
measure: change in Hemoglobin concentration
timeFrame: At time 0 (enrollment),1 and 2 months
Secondary outcomes:
measure: Serum ferritin
timeFrame: At time 0 (enrollment) and 2 months
measure: mean cell volume (MCV)
timeFrame: At time 0 (enrollment) and 2 months
measure: mean corpuscular hemoglobin (MCH)
timeFrame: At time 0 (enrollment) and 2 months
measure: mean cell hemoglobin concentration (MCHC)
timeFrame: At time 0 (enrollment) and 2 months
measure: cost
timeFrame: 1-2 months
measure: percentage of women who agree to take each of the two drugs for a future whole pregnancy.
timeFrame: At time 0 (enrollment) and every 2 weeks, for 2 months
measure: Side effects:
timeFrame: At time 0 (enrollment) and every 2 weeks, for 2 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Mai Mahmoud Mohamed
Study officials:
affiliation: personal
name: Sherif A Ashoush, a. professor
role: STUDY_CHAIR
References: