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Comparison of daily oral iron treatment with alternate day treatment for correction of iron deficiency anemia

Daily versus alternate day oral iron replacement in Iron deficiency anemia:A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038370
Enrollment
112
Registered
2021-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: D508- Other iron deficiency anemias

Interventions

Intervention1: Ferrous sulphate 200mg tablet containing 60mg of elemental iron: Ferrous sulphate 400mg tablets, containing 120mg of elemental iron (2 x 200mg tablets given together) given as single do

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed iron deficiency anaemia patients, with haemoglobin concentration between 6-10 g/dl, with peripheral blood smear suggestive of iron deficiency anemia and with serum ferritin level <30 mcg/l

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women 2. Already diagnosed to have iron deficiency anemia and on treatment 3. Known coronary artery disease/chronic heart failure 4. History of overt gastrointestinal bleeding (haematemesis/ melena) 5. Chronic kidney disease (serum creatinine >2 mg/dl) 6. Known malabsorption 7. Heavy alcohol abuse (alcohol intake >once/week) 8. Dimorphic anaemias 9. History of peptic ulcer disease on long term acid suppressive therapy 10. Known anaemia of chronic disease (SLE/rheumatoid arthritis/HIV infection/ Tuberculosis)

Design outcomes

Primary

MeasureTime frame
To assess the quantum of haemoglobin increment in once daily and alternate day oral iron replacement arms on Day-28Timepoint: To assess the quantum of haemoglobin increament in once daily and alternate day oral iron replacement on Days-14 and 28

Secondary

MeasureTime frame
1.To study the effect of oral iron replacement on serum hepcidin levels in the two arms at baseline and on Day-14 2.To determine frequency of adverse events and compliance with therapy in the two arms 3.To assess the increment in haemoglobin concentration in the two arms on Day-56Timepoint: Day-0 (Start of intervention), Day-7,Day-14,Day-28,Day-42 and Day-56

Countries

India

Contacts

Public ContactDr Vinod K V

JIPMER, Pondicherry-06

drkvv@rediffmail.com9442604554

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026