Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Lupiheme, Corcium XT: Lupiheme: Heme Iron Polypeptide (HIP) {Generic drug (Lupin Ltd)}
Corcium XT: Calcium Carbonate 1250 mg IP [500 mg elemental calcium] + Vitamin D3 2000 IU + Mecobalamin IP 1500 mcg + L-Methyl folate calcium 1mg + Pyridoxal-5-Phosphate IP 20mg {Generic drug (Lupin Lt
Sponsors
Lupin Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Pregnant woman aged 18 to 40 years. Singleton pregnancy with gestational age between 12 to 18 weeks, confirmed by early trimester ultrasound. Diagnosed with mild to moderate iron deficiency Anaemia, defined as Haemoglobin (Hb) between 8.0 and 10.9 g/dL and Serum ferritin less than 30 g/L Belongs to either of the following two groups: Iron therapy-na ve: Has not yet received oral or parenteral iron during the current pregnancy Oral iron intolerant: Has received standard oral iron therapy for greater than 2 weeks and complained of GI intolerance. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they have received parenteral iron therapy within the last four weeks; have known hypersensitivity to heme based products or previous reaction to HIP; have anemia due to other causes including hemoglobinopathies, vitamin B twelve deficiency, folate deficiency, chronic renal disease, active infection or inflammation, or chronic blood loss; have poorly controlled type two diabetes defined as random blood glucose equal to or greater than two hundred milligrams per deciliter at screening; have chronic hypertension defined as systolic blood pressure equal to or greater than one hundred forty millimeters of mercury or diastolic blood pressure equal to or greater than ninety millimeters of mercury at screening; have tuberculosis, viral hepatitis, human immunodeficiency virus infection, cirrhosis, malabsorption syndrome, cardiovascular disease, renal disease, autoimmune disease, cancer, or any other clinically significant systemic illness that may interfere with iron absorption or metabolism; or have participated in another interventional clinical study within the past thirty days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in haemoglobin (g/dL)Timepoint: From baseline to end of visit 3 (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in haemoglobin (g/dL)Timepoint: At visit 1 and 2 (week 4, 8 respectively from the start of treatment) compared to baseline visit;Mean change in serum ferritinTimepoint: from baseline to final visit 3 (week 12);Mean change in serum ironTimepoint: from baseline to final visit 3 (week 12);The effect of timing of calcium and multivitamin supplements on haemoglobin response by evaluating the mean change in haemoglobin (g/dL)Timepoint: from baseline to visit 3 (week 12);change in numerical rating scale score regarding participant s global assessment of diseaseTimepoint: at each visit;Incidents of adverse effects to evaluate the safety and tolerability of HIPTimepoint: at each visit | — |
Countries
India
Contacts
Public ContactDr Pranav Gawande
Seth G S Medical College and KEM Hospital
Outcome results
None listed