Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy
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|ClinicalTrials.gov Identifier: NCT03202615|
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anemia During Pregnancy||Dietary Supplement: L (lactoferrin) Drug: F (ferrous sulphate)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Bovine Lactoferrin Versus Ferrous Sulphate In The Treatment Of Iron Deficiency Anemia During Pregnancy: A Randomized Controlled Trial|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: L (lactoferrin in IDA with pregnancy)
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.
Dietary Supplement: L (lactoferrin)
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
Other Name: Pravotin sachets
Active Comparator: F (ferrous sulphate with pregnancy)
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.
Drug: F (ferrous sulphate)
Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.
Other Name: Ferrofol capsules
- change in Hemoglobin concentration [ Time Frame: At time 0 (enrollment),1 and 2 months ]grams/dL
- Serum ferritin [ Time Frame: At time 0 (enrollment) and 2 months ]nanograms per milliliter
- mean cell volume (MCV) [ Time Frame: At time 0 (enrollment) and 2 months ]fL/red cell in adult
- mean corpuscular hemoglobin (MCH) [ Time Frame: At time 0 (enrollment) and 2 months ]picograms (pg)/cell in adults
- mean cell hemoglobin concentration (MCHC) [ Time Frame: At time 0 (enrollment) and 2 months ]g/dL
- cost [ Time Frame: 1-2 months ]The average drug cost by LE.
- percentage of women who agree to take each of the two drugs for a future whole pregnancy. [ Time Frame: At time 0 (enrollment) and every 2 weeks, for 2 months ]percentage
- Side effects: [ Time Frame: At time 0 (enrollment) and every 2 weeks, for 2 months ]
scaling score of side effects of oral administration of bLf and ferrous sulfate as:
- gastrointestinal discomfort
- heart burn
- constipation The degree of side effects will be assessed using objective scaling scoring system: 0 (no symptoms), 1 (mild not requiring any change in life style), 2 (severe controlled with another method), 3 (severe not controlled but accepting), 4 (severe not controlled and not accepting).
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): NCT03202615
|Contact: Mai M Abdelwahed, specialist||01152684127 ext firstname.lastname@example.org|
|Contact: Gihan E El Hawwary, specialist||01210333986 ext 002|
|Mai Mahmoud Mohamed||Recruiting|
|Alexandria, Egypt, 12345|
|Contact: Mai Ms Abdelwahed, Master 01152684127 ext 002 email@example.com|
|Contact: Sherif Mr Ashoush, Doctoral 01222660266 ext 002 firstname.lastname@example.org|
|Study Chair:||Sherif A Ashoush, a. professor||personal|