Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial

Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy

Sponsors

Lead sponsor: Abdelwahed, Mai Mahmoud Mohamed, M.D.

Source Abdelwahed, Mai Mahmoud Mohamed, M.D.
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.

Overall Status Recruiting
Start Date September 2015
Completion Date October 2018
Primary Completion Date August 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
change in Hemoglobin concentration At time 0 (enrollment),1 and 2 months
Secondary Outcome
Measure Time Frame
Serum ferritin At time 0 (enrollment) and 2 months
mean cell volume (MCV) At time 0 (enrollment) and 2 months
mean corpuscular hemoglobin (MCH) At time 0 (enrollment) and 2 months
mean cell hemoglobin concentration (MCHC) At time 0 (enrollment) and 2 months
cost 1-2 months
percentage of women who agree to take each of the two drugs for a future whole pregnancy. At time 0 (enrollment) and every 2 weeks, for 2 months
Side effects: At time 0 (enrollment) and every 2 weeks, for 2 months
Enrollment 130
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: L (lactoferrin)

Description: Dietary Supplement: Pravotin sachets (Hygint, Egypt) containing bLf One sachet of Pravotin contains 100 mg of bLf. Dosage: one sachet twice a day before meals with placebo tablets

Arm group label: L (lactoferrin in IDA with pregnancy)

Other name: Pravotin sachets

Intervention type: Drug

Intervention name: F (ferrous sulphate)

Description: Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.

Arm group label: F (ferrous sulphate with pregnancy)

Other name: Ferrofol capsules

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.

Gender: Female

Minimum age: 20 Years

Maximum age: 30 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sherif A Ashoush, a. professor Study Chair personal
Overall Contact

Last name: Mai M Abdelwahed, specialist

Phone: 01152684127

Phone ext: 002

Email: [email protected]

Location
facility status contact contact_backup
Mai Mahmoud Mohamed Recruiting Mai Ms Abdelwahed, Master 01152684127 002 [email protected]
Location Countries

Egypt

Verification Date

July 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: L (lactoferrin in IDA with pregnancy)

Arm group type: Experimental

Description: Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 100 mg bLf granules (Pravotin sachets , Hygint, Egypt) in 1/4 glass of water twice a day before meals in addition to placebo tablets three time per day on an empty stomach.

Arm group label: F (ferrous sulphate with pregnancy)

Arm group type: Active Comparator

Description: Pregnant women with IDA, in the 2nd trimester are enrolled and treated for 2 months regularly with oral administration of 150 mg of dried ferrous sulphate capsules (Ferrofol capsules, Eipico, Egypt), one capsule three times daily on an empty stomach, at least 1 hour before or 2 hours after meals, in addition to placebo sachets (starch) twice a day.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov