Comparison of once daily (120 mg) versus twice daily (60 mg) elemental iron supplementation for improvement of hemoglobin levels among pregnant mothers with iron deficiency anaemia attending the antenatal clinic at German Sri Lanka Friendship Hospital for Women: A randomized controlled trial

Assessment of the efficacy of two different dosing regimens of elemental iron supplementation (60mg twice daily vs 120mg once daily) in the treatment of iron deficiency anemia (IDA) among pregnant mothers attending the antenatal clinic at the German Sri Lanka Friendship Hospital for Women

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2026/012

Enrollment

Unknown

Registered

2026-06-09

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Iron Deficiency Anemia (IDA) in pregnancy

Interventions

The study will be carried out at the antenatal clinic of the German Sri Lanka Friendship Hospital for Women (Teaching Hospital Mahamodara). Participants will be allocated to one of two treatment gro

Eligibility

Inclusion criteria

Inclusion criteria: - Pregnant mothers aged 18–40 years attending the antenatal clinic at German Sri Lanka Friendship Hospital for Women - Gestational age < 27 weeks - Singleton pregnancy - Hemoglobin < 11 g/dL in first trimester and < 10.5 g/dL in second trimester - Serum ferritin < 30 ng/mL

Exclusion criteria

Exclusion criteria: - Known hemoglobinopathies (thalassemia, sickle cell disease) - Chronic medical disorders affecting anemia management (e.g. chronic kidney disease, chronic liver disease, inflammatory disorders) - Recent blood transfusion within the last 3 months - Multiple pregnancy - History of severe intolerance to oral iron - Ongoing significant bleeding disorders - Pregnant mothers who decline consent

Design outcomes

Primary

Measure	Time frame
The hemoglobin (Hb) level changes after 2 weeks of iron supplementation and expect hemoglobin rise of 0.8-1 g/dL at the end of 2 weeks [End of the 2 weeks from starting iron supplementation]	—

Secondary

Measure	Time frame
• Assessing the compliance of taking iron tablets as a single dose and two doses per day • Comparison of side effects of taking iron tablets as a single dose and two doses per day • Assessing the awareness and practices of taking iron tablet • Assessing the increment of hemoglobin level and ferritn in three months An interviewer-administered questionnaire will be used [in-house] to collect participant details. The research assistant will give serial numbers to each pregnant mother, preserving allocation concealment. The questionnaire contains following domains. Part I – Sociodemographic information Part II – Obstetric data Part III - Maternal compliance, severity of side effects to iron treatment, and awareness of taking iron tablets. Part IV- Post treatment Hb value and ferritin value [End of the 2 weeks from starting iron supplementation ]	—

Measure

Time frame

• Assessing the compliance of taking iron tablets as a single dose and two doses per day • Comparison of side effects of taking iron tablets as a single dose and two doses per day • Assessing the awareness and practices of taking iron tablet • Assessing the increment of hemoglobin level and ferritn in three months An interviewer-administered questionnaire will be used [in-house] to collect participant details. The research assistant will give serial numbers to each pregnant mother, preserving allocation concealment. The questionnaire contains following domains. Part I – Sociodemographic information Part II – Obstetric data Part III - Maternal compliance, severity of side effects to iron treatment, and awareness of taking iron tablets. Part IV- Post treatment Hb value and ferritin value [End of the 2 weeks from starting iron supplementation ]

—

Countries

Sri Lanka

Contacts

Public ContactYapa Mudiyanselage Dayasiri Anusitha Bandara

Senior Registrar

anusitha5@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026