A clinical trial to study the efficacy of three drugs (Oral liposomal iron, Oral ferrous sulphate and Intravenous iron sucrose) in pregnant women between 16-28 weeks of gestation with Moderate anemia.

Efficacy of Oral liposomal iron, Oral Ferrous sulphate, and Intravenous iron sucrose in antenatal women between 16-28 weeks of gestation with moderate anaemia - A Randomized controlled Trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071860

Enrollment

120

Registered

2024-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O269- Pregnancy related conditions, unspecified

Interventions

Intervention1: LIPOSOMAL IRON(Ferrous Pyrrophosphate): 30MG (1 - 0 - 1) per oral administration twice daily for 4 weeks Control Intervention1: FERROUS SULPHATE: 60MG (1 - 0 - 1) per oral administrati

Eligibility

Inclusion criteria

Inclusion criteria: 1) Antenatal women between 16 to 28 weeks of gestation. 2) Antenatal women with Hemoglobin level between 7 – 9.9g% (Moderate anemia according to WHO) 3) Women with established iron deficiency anemia 4) Women with no prior history of blood transfusion

Exclusion criteria

Exclusion criteria: 1) Antenatal women belong to First trimester (1-12 weeks of gestation) and more than 32 weeks of gestation 2) Women with medical complications/ Hematological disorders 3) Women with Hemoglobinopathies 4) Liver disorder like jaundice, cirrhosis, or renal failure 5) Antenatal women with Hemoglobin level less than 7g%

Design outcomes

Primary

Measure	Time frame
Increase in Hemoglobin levels after taking the prescribed or administered drug to the patient over a period of 4 weeks in which we will study the Efficacy of Oral liposomal iron when compared to Oral ferrous sulphate and Intravenous iron sucrose in treatment of moderate anemia in pregnancy.Timepoint: 4 weeks	—

Secondary

Measure	Time frame
1) To study the patient’s compliance of oral liposomal iron in treatment of anemia in pregnancy. 2) To observe the compliance of oral ferrous sulphate in treatment of anemia in pregnancy. 3) To observe and compare the side effects of oral liposomal iron VS oral ferrous sulphate in treatment of anemia in pregnancy. 4) To observe the adverse effects of intravenous iron sucrose in treatment of anemia in pregnancy. Timepoint: 4 weeks	—

Measure

Time frame

1) To study the patient’s compliance of oral liposomal iron in treatment of anemia in pregnancy. 2) To observe the compliance of oral ferrous sulphate in treatment of anemia in pregnancy. 3) To observe and compare the side effects of oral liposomal iron VS oral ferrous sulphate in treatment of anemia in pregnancy. 4) To observe the adverse effects of intravenous iron sucrose in treatment of anemia in pregnancy. Timepoint: 4 weeks

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Countries

India

Contacts

Public ContactShobika B

Aarupadai Veedu Medical College and Hospital

deepa.shanmugam@avmc.edu.in8012081902

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026