Iron-deficiency
Conditions
Keywords
Iron, Deficiency
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.
Interventions
DRUGLactoferrin
parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia
DRUGIron Supplement
Iron Sulphate 150 mg once daily
DRUGChelates, Iron
Amino acid chelated iron capsules contain 15 mg
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double blinded (participant and care giver)
Intervention model description
3 groups of pregnant women will be assigned for each intervention
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in haemoglobin level after 4 weeks of use. | 4 weeks | difference in haemoglobin levelbetween before and after supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Egypt
Outcome results
None listed