Efficacy of ferrous ascorbate versus ferrous sulfate and ferrous fumarate in women with iron-deficiency anemia in pregnancy: a multi-centre randomized controlled trial

Phase 3

Not yet recruiting

• Conditions: Iron deficiency anaemia in pregnancy

• Registration Number: SLCTR/2023/018
• Lead Sponsor: Zydus Lifesciences Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 396

Inclusion Criteria

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.

Exclusion Criteria

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