Supplementation of Vitamin D3 in Iron deficient anemic pregnant wome
- Conditions
- Health Condition 1: null- Iron deficiency anemic pregnant women
- Registration Number
- CTRI/2018/04/012997
- Lead Sponsor
- JSS UNIVERSITY Mysuru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
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 < 12µg/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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method RBC Count <br/ ><br>Hematocrit <br/ ><br>Serum Iron <br/ ><br>Transferrin saturation <br/ ><br>Total Iron binding capacity <br/ ><br>Mean Corpuscular Volume (MCV) <br/ ><br>Mean Corpuscular Hemoglobin (MCH) <br/ ><br>PTH <br/ ><br>Calcium and Creatinine <br/ ><br>Symptoms of anemia <br/ ><br>Weight Gain <br/ ><br>Blood Transfusion <br/ ><br>Timepoint: Change in Vitamin D, Ferritin, Hemoglobin Concentration, and serum iron and transferrin saturation from Baseline Visit 1 to Visit 4