Oral Lactoferrin Versus Iron Supplementation During Pregnancy

Phase 4

Completed

• Conditions: Iron-deficiency
• Interventions: Drug: Chelates, Iron; Drug: Iron Supplement; Drug: Lactoferrin

• Registration Number: NCT03542825
• Lead Sponsor: South Valley University

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-05-20
• Study First Submitted QC: 2018-05-20
• Study First Posted: 2018-05-31
• Primary Completion: 2018-09-01
• Study Completion: 2018-10-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amino acid Chelated	Chelates, Iron	amino acid chelated iron capsule 15mg for 3 consecutive months.
Iron Sulphate	Iron Supplement	ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months.
Lactoferrin	Lactoferrin	lactoferrin 100 mg sachets once daily for 3 consecutive months.

Primary Outcome Measures

Name	Time	Method
change in haemoglobin level after 4 weeks of use.	4 weeks	difference in haemoglobin levelbetween before and after supplementation

Secondary Outcome Measures

Name	Time	Method
side effect profile	4 weeks	All women will be asked to keep a diary of five potential gastrointestinal side effects (Epigastric pain, nausea, vomiting, diarrhoea and constipation).

Trial Locations

Locations (1)

South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department; 🇪🇬 Qinā, Qena, Egypt