A Phase 2 interventional study of Lactoferrin and ferrous sulphate + folic acid (vitamin B9) in Iron Deficiency Anemia of Pregnancy, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Ain Shams Maternity Hospital · Phase 2, Interventional, and Treatment
This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy.
Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.
Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy.
Ferrous sulphate is the most commonly used treatment for iron deficiency anemia.
Lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.
Drug: Lactoferrin
150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.
Drug: ferrous sulphate + folic acid (vitamin B9)
(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.
Also known as: Pravotin, MamyVital
Drug page: Folic Acid
(Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks.
Also known as: Ferrofol
Hemoglobin (Hb) level.
to be measured before and after treatment.
Time frame: 4 weeks
serum ferritin level.
to be measured before and after treatment.
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Mar 2018, 6 months.
Of 16 phase 2 interventional studies under Anemia, Iron-Deficiency, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lactoferrin · Folic Acid
Ain Shams Maternity Hospital →