Skip to main content
OpenTrials
Completed

NCT Number: NCT03542825

Oral Lactoferrin Versus Iron Supplementation During Pregnancy

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].

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department

Qina, Qena Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lactoferrin

Drug

parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia

Iron Supplement

Drug

Iron Sulphate 150 mg once daily

Other names: Iron Sulphate

Chelates, Iron

Drug

Amino acid chelated iron capsules contain 15 mg

Other names: Amino acid chelated iron

Primary outcomes

  1. change in haemoglobin level after 4 weeks of use.

    Time frame: 4 weeks

    difference in haemoglobin levelbetween before and after supplementation

Secondary outcomes

  1. side effect profile

    Time frame: 4 weeks

    All women will be asked to keep a diary of five potential gastrointestinal side effects (Epigastric pain, nausea, vomiting, diarrhoea and constipation).

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 31, 2018
Registry last updated
Dec 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.