Oral Lactoferrin Versus Iron Supplementation During Pregnancy
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 11/30/2018 |
| Primero enviado: | 05/19/2018 |
| Inscripción estimada enviada: | 05/19/2018 |
| Publicado por primera vez: | 05/30/2018 |
| Última actualización enviada: | 12/26/2018 |
| Última actualización publicada: | 12/27/2018 |
| Fecha de inicio real del estudio: | 12/31/2017 |
| Fecha estimada de finalización primaria: | 08/31/2018 |
| Fecha estimada de finalización del estudio: | 09/30/2018 |
Condición o enfermedad
Intervención / tratamiento
Drug: Lactoferrin
Drug: Iron Sulphate
Drug: Amino acid Chelated
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Iron Sulphate ferrous sulphate 150 mg iron capsule once daily for 3 consecutive months. | Drug: Iron Sulphate Iron Sulphate 150 mg once daily |
| Active Comparator: Amino acid Chelated amino acid chelated iron capsule 15mg for 3 consecutive months. | Drug: Amino acid Chelated Amino acid chelated iron capsules contain 15 mg |
| Active Comparator: Lactoferrin lactoferrin 100 mg sachets once daily for 3 consecutive months. | Drug: Lactoferrin parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia |
Criterio de elegibilidad
| Edades elegibles para estudiar | 20 Years A 20 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | 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). |
Salir
Medidas de resultado primarias
1. change in haemoglobin level after 4 weeks of use. [4 weeks]
Medidas de resultado secundarias
1. side effect profile [4 weeks]
