Vitamin D supplementation in Iron Deficiency anemia among pregnant women: An open label prospective Interventional study

JSS UNIVERSITY Mysuru0 个研究点目标入组 210 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Maternal age of 18 years or greater at the time of consent
•2.The ability to provide written informed consent
•3.Confirmed singleton pregnancy on or before 13 weeks of gestation at the time of consent as defined by their last menstrual period or determined by ultrasound
•4.Planned to receive on-going prenatal care
•5.Iron deficiency anemia with average hemoglobin ranging from 10-10.9 and 7-9.9g/dL at the onset of study and serum ferritin < 12Âµg/L
•6.No history of blood transfusion 120days prior to first visit
•7.Pregnant women with or with the condition of anemia and vitamin D deficiency
•8.Pregnant women with condition of vitamin D less than 30 nmol/L or 12ng/ml
•9.Pregnant women already on routine medication prescribed by the treating physician (Folic acid 0.5mg + FeSo4 333mg (100 mg of elemental iron) OD in the morning2.Calcium 300 mg OD in the noon 3.Vitamin B-Complex tablet (Vitamin B1: 2mg, Vitamin B2 2 mg, vitamin B6 0.5mg, Nicacinamide 25mg, Calcium Pantothenate 1mg) OD in the morning).

•Exclusion Criteria:
•1.Severe anemia (Hb <7g/L).
•2.Pregnant women with pre-existing calcium or who required chronic diuretic or cardiac medication therapy, including calcium channel blockers, or who suffered chronic hypertension
•3.Pregnant women with active thyroid disease (eg, Gravesâ?? disease, Hashimoto disease, or thyroiditis), but mothers on thyroid supplement with normal serologic parameters could participate in the study if they are without any other endocrine dysfunction.
•4.Patient with seizure disorders
•5.History of anemia due to other causes or chronic blood loss, hemolyticanemia or thalassemia
•6.History of hepatic and renal abnormality
•7.Known peptic ulcer, esophagitis, gastritis or hiatus hernia
•8.Family history of thalassemia, sickle cell anemia or malabsorption syndrome.
•9.History of high risk pregnancy including abruption placenta, placenta previa, gestational diabetes, coagulation disorders, thrombocytopenia or history of drug abuse.
•10.Chronic hematological disease, hereditary defects of red cells or hemoglobin.
•11.Patient with Multiple pregnancy
•12.Allergy to study medications
•Elimination criteria:
•13.Blood hemoglobin levels become less than 7 g/dl during the course of treatment
•14.Any other acute illness during the course of treatment
•15.Subject not willing to continue the treatment
•16.Any severe untoward effect

发起方

JSS UNIVERSITY Mysuru