Oral Lactoferrin Versus Iron Supplementation During Pregnancy

South Valley University

Status and phase: Completed; Phase 4

Conditions: Iron-deficiency

Treatments: Drug: Iron Supplement; Drug: Chelates, Iron; Drug: Lactoferrin

Study type: Interventional

Funder types: Other

Identifiers

NCT03542825

OBGYN 003

Details and patient eligibility

About

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].

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Iron Sulphate

Active Comparator group

Description:

ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months.

Treatment:

Drug: Iron Supplement

Amino acid Chelated

Active Comparator group

Description:

amino acid chelated iron capsule 15mg for 3 consecutive months.

Treatment:

Drug: Chelates, Iron

Lactoferrin

Active Comparator group

Description:

lactoferrin 100 mg sachets once daily for 3 consecutive months.

Treatment:

Drug: Lactoferrin