Oral Lactoferrin Versus Iron Supplementation During Pregnancy

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542825
• Other study ID #: OBGYN 003
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: December 2018
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women (aged 20-40 yrs.) with single fetus, in the second trimester, with normal haemoglobin level (Hb level =10.5 gm /dl) will be enrolled.

Exclusion Criteria:

• Women with anaemia (Hb level =10.5 gm. /dl) due to any causes, such as chronic blood loss, haemolytic anaemia and thalassemia (including thalassemia trait).

• History of peptic ulcer.

• Medical complications with pregnancy (such as cardiovascular, thyroid, pituitary, nutritional, renal, liver diseases, diabetes mellitus (DM) and hypertension (HTN).

• Fetal abnormalities such as microcephaly, intrauterine growth restriction (IUGR).

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

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

Locations

Country	Name	City	State
Egypt	South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department	Qina	Qena

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Abu Hashim H, Foda O, Ghayaty E. Lactoferrin or ferrous salts for iron deficiency anemia in pregnancy: A meta-analysis of randomized trials. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:45-52. doi: 10.1016/j.ejogrb.2017.10.003. Epub 2017 Oct 4. Review. — View Citation

Baker EN, Baker HM. Molecular structure, binding properties and dynamics of lactoferrin. Cell Mol Life Sci. 2005 Nov;62(22):2531-9. Review. — View Citation

Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. Erratum in: Br J Haematol. 2012 Aug;158(4):559. — View Citation

Sharma JB, Jain S, Mallika V, Singh T, Kumar A, Arora R, Murthy NS. A prospective, partially randomized study of pregnancy outcomes and hematologic responses to oral and intramuscular iron treatment in moderately anemic pregnant women. Am J Clin Nutr. 2004 Jan;79(1):116-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in haemoglobin level after 4 weeks of use.	difference in haemoglobin levelbetween before and after supplementation	4 weeks
Secondary	side effect profile	All women will be asked to keep a diary of five potential gastrointestinal side effects (Epigastric pain, nausea, vomiting, diarrhoea and constipation).	4 weeks