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Comparing daily and alternate day iron treatment for improving anemia in children

Alternate Day Versus Daily Oral Iron for Treatment of Iron Deficiency Anemia in Children A Randomized Controlled Trial - ADDI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/113058
Enrollment
200
Registered
2026-06-22
Start date
Unknown
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

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: Oral iron supplementation alternate day: Oral elemental iron 3 mg per kg per dose administered on alternate days for a total duration of 12 weeks in children with iron deficiency anemia

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 months to 12 years Diagnosed with Iron Deficiency Anemia defined by Hemoglobin below WHO age appropriate cut offs Peripheral smear showing microcytic hypochromic anemia Low MCV MCH ratio increased RDW Low Serum ferritin less than 15 ng per mL Nutritional anemia suspected as the primary cause Attending OPD and IPD Dept Of Paediatrics Trichy SRM Medical College Informed written consent obtained from parent and guardian

Exclusion criteria

Exclusion criteria: Children on iron therapy or blood transfusion within the past 3 months Known malabsorption syndromes celiac disease IBD Children with significant comorbidities making follow up difficult Refusal of parental guardian consent

Design outcomes

Primary

MeasureTime frame
Improvement in hemoglobin concentration measured as change from baseline to 12 weeks.Timepoint: Baselin, 12 weeks

Secondary

MeasureTime frame
Gastrointestinal tolerability will be assessed using a structured caregiver questionnaire documenting symptoms such as nausea, vomiting, abdominal pain, constipation and diarrhea at baseline, 4 weeks and 12 weeks. Treatment compliance will be assessed at 4 weeks and 12 weeks using the syrup bottle method and expressed as percentage of prescribed dose and categorized as good or poor adherence. Outcomes will be reported as proportion of children with adverse effects, severity distribution, mean compliance and proportion with good adherence. Treatment discontinuation and loss to follow up will also be recorded.Timepoint: Baseline, 4 weeks, 12 weeks

Countries

India

Contacts

Public ContactDr M Aravind

Trichy SRM Medical College Hospital and Research Center

muthuvelbalasubramaniyan@gmail.com6381054001

Outcome results

None listed

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