Health Condition 1: null- Iron deficiency anemic pregnant women
Conditions
Interventions
Intervention1: Vitamin D: 1000IU
Control Intervention1: Dietary supplement: Vitamin D3 1000 IU Per oral once Daily: Other : Placebo One tablet per oral once daily
Sponsors
JSS UNIVERSITY Mysuru
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria: Exclusion Criteria: 1.Severe anemia (Hb 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Vitamin D, Ferritin, Hemoglobin Concentration, and serum iron and transferrin saturation from Baseline Visit 1 to Visit 4Timepoint: Change in Vitamin D, Ferritin, Hemoglobin Concentration, and serum iron and transferrin saturation from Baseline Visit 1 to Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| RBC Count Hematocrit Serum Iron Transferrin saturation Total Iron binding capacity Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) PTH Calcium and Creatinine Symptoms of anemia Weight Gain Blood Transfusion Timepoint: Change in Vitamin D, Ferritin, Hemoglobin Concentration, and serum iron and transferrin saturation from Baseline Visit 1 to Visit 4 | — |
Countries
India
Contacts
Public ContactRoopa Satyanarayan Basutkar
JSS College of Pharmacy
Outcome results
None listed