NCT03542825

Oral Lactoferrin Versus Iron Supplementation During Pregnancy

Outcome of Oral Lactoferrin in Comparison to Amino Acid Chelated Iron and Ferrous Sulphate Supplementation During Pregnancy: A Randomized Control Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: South Valley University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores \[Sharma JB; et al., 2004\]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection \[ So¨lvell L; et al., 1970\].

Detailed description

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores. This allows the normal mechanism of absorption to be used, in addition to being an inexpensive and effective treatment \[Sharma JB; et al., 2004\]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection \[ So¨lvell L; et al., 1970\]. Furthermore, routine iron supplementation has recently been challenged. The British Society for Hematology, Obstetric Hematology Group (BSH OHG) and the British Committee for Standards in Hematology (BCSH) recommend screening by Full blood count (FBC) at booking and at 28 weeks instead of universal iron supplementation \[Pavord S. 2012\]. Lactoferrin is a high-affinity cationic iron binding glycoprotein \[Baker EN, 2005\]. Bovine Lactoferrin is currently available pharmaceutical preparation. It is in to safe and effective in treating pregnant women suffering from ID and IDA \[Mohamed Rezk, et al. 2015\]. This study will compare the efficacy of these three available options.

Conditions

• Iron-deficiency

Interventions

Type	Name	Description
DRUG	Lactoferrin	parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia
DRUG	Iron Supplement	Iron Sulphate 150 mg once daily
DRUG	Chelates, Iron	Amino acid chelated iron capsules contain 15 mg

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-09-01
• Completion: 2018-10-01
• First posted: 2018-05-31
• Last updated: 2018-12-28

Locations

1 site across 1 country: Egypt