Oral Lactoferrin Versus Iron Supplementation During Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Iron-deficiency

Intervention / Treatment
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* Drug: Lactoferrin
* Drug: Iron Supplement
* Drug: Chelates, Iron


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 groups of pregnant women will be assigned for each intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron Sulphate<br>ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months. | Drug: Iron Supplement<br>* Iron Sulphate 150 mg once daily<br>* Other names: Iron Sulphate;|
| Active Comparator: Amino acid Chelated<br>amino acid chelated iron capsule 15mg for 3 consecutive months. | Drug: Chelates, Iron<br>* Amino acid chelated iron capsules contain 15 mg<br>* Other names: Amino acid chelated iron;|
| Active Comparator: Lactoferrin<br>lactoferrin 100 mg sachets once daily for 3 consecutive months. | Drug: Lactoferrin<br>* parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in haemoglobin level after 4 weeks of use. | difference in haemoglobin levelbetween before and after supplementation | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron, Deficiency