Efficacy of ferrous ascorbate versus ferrous sulfate and ferrous fumarate in women with iron-deficiency anemia in pregnancy: a multi-centre randomized controlled trial
- Conditions
- Iron deficiency anaemia in pregnancy
- Registration Number
- SLCTR/2023/018
- Lead Sponsor
- Zydus Lifesciences Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 396
1.Pregnant female (gestational age 14 to 24 weeks).
2.Aged 18 years and above.
3.Hemoglobin levels <11 g/dl but >7 g/dl and serum ferritin < 30 µg/dl.
4.A diagnosis of iron deficiency anaemia based on the blood picture.
1.Hypersensitivity to iron supplements
2.Reported intolerance to iron supplements in the past
3.Severe anemia requiring parentral transfusion or transfusion of blood products
4.Known diagnosis of anemia related to causes other than iron deficiency (thalassemia, chronic disease, sickle cell, sideroblastic anaemia etc.)
5.Hemochromatosis or iron overload
6.Malabsorptive, ulcerative or inflammatory gastro-intestinal disease
7.History of serious progressive or chronic inflammatory disease (cardiac, renal, hepatic, oncological, autoimmune or any other systemic disease)
8.Undergone surgery in one month before enrolment or planned to undergo surgery during the course of study
9.Subject simultaneously participating in any other clinical studies or having participated in any other clinical trial in the past 3 months.
OR
10.History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, bariatric or bowel surgery, HIV infection, or severe coronary artery disease).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of women who achieve a Hb>11 g/dl.<br><br> [Baseline and every 4 weeks till end point or Hb at admission for delivery]<br>The duration of therapy required to achieve a Hb =11 g/dl in each group. [Baseline and every 4 weeks till end point or Hb at admission for delivery]<br>
- Secondary Outcome Measures
Name Time Method