Objectives 

Primary: To compare the efficacy of daily oral ferrous sulphate supplementation at a 6 mg per kg vs 3 mg per kg in children aged 3months to 5years with moderate and severe iron deficiency anemia in terms of proportion of non-anemic children after 12 weeks of therapy

 Secondary: To compare the two groups with respect to 1) Rise in hemoglobin at week 2, 8 and 12 weeks of therapy, 2) Change in ferritin levels after 12 weeks of therapy 3) Compliance and adherence to oral iron therapy 4) Adverse effects experienced  5) Proportion of non-anemic children at 8 weeks among those taking daily oral ferrous sulphate supplementation at 6 mg per kg VS 3 mg per kg in children with moderate and severe iron deficiency anemia.

Study Setting: Department of Pediatrics and Biochemistry, UCMS and GTB Hospital, Delhi.

Study Design: Open label, Randomized control trial

Study Duration: August 2025 to  November 2026

Ethics: Approval will be obtained from the Institutional Ethics Committee for Human Research. 

Consent: Written informed consent will be taken from the parents/caregivers of participants enrolled. 

Trial Registry: The trial will be registered in the Clinical Trial Registry of India (CTRI).

Participants: 

Inclusion Criteria: All children (3 months - 5 years) with moderate and severe iron deficiency anemia (IDA) will be enrolled. Iron deficiency anemia will be defined as moderate (Hb-7-9.4 g per dl in less than 2 years & Hb- 7-9.9 g per dl in more than 2 years)  and severe (Hb- less than 7 g per dl) with peripheral blood smear suggestive of microcytic hypochromic picture AND low mean corpuscular volume (MCV) (upto 2 year less than 70 fl and  2 to 5 year less than 70 plus age in years) (5) AND serum ferritin less than 12 mcg per L in the absence of infection and less than 30 mcg per L in the presence of infection. 

Intervention: Stratified Block randomization will be done. Participants will be divided into strata based on Hb levels as severe anemia (Hb less than 7 g per dL) and moderate anemia (Hb-7-9.4g per dl in less than 2 years, Hb-7-9.9 g per dL 2-5 years) will be used to assign patients at 6 mg per kg or 3 mg per kg of daily oral ferrous sulphate. Detailed clinical history including birth history and dietary history, physical examination and anthropometry as per the WHO criteria will be conducted and recorded in a pre-designed proforma. For estimation of complete blood count (CBC), peripheral smear and CRP, 2 ml venous sample will be taken and another 2 ml venous sample will be taken for estimation of serum ferritin. Patients who meet the eligibility criteria will receive a single daily dose of syp. ferrous sulphate at either 6 mg per kg or 3 mg per kg for 12 weeks. Participants will be followed up on week 1,2, 4, 8 and 12 and details regarding compliance will be assessed and adverse effects will be enquired. Complete hemogram will be assessed after 2, 8 and 12 weeks using 1 ml venous blood in ethylene diamine tetra acetate (EDTA) vacutainer. Serum ferritin will be estimated at 12 weeks using a 2 ml peripheral venous blood sample.

Sample Size: Total 122, 61 in each group

Outcome Variables: 

Primary outcome: Proportion of non-anemic children after 12 weeks of therapy.

Secondary Outcome:1) Change in Hb after 2, 8, 12 weeks of therapy. 2) Serum ferritin level on week 12.

 3) Proportion of participants compliant to oral iron therapy in the two groups 4) Adverse effects experienced among the two group 5) Proportion of non-anemic children at 8 weeks.

Statistical analysis: Collected data will be entered in the excel sheet and will be analyzed. Categorical variables including proportion of non-anemic children at 8 and 12 weeks in both groups will be analyzed using Chi-square test. Serum hemoglobin levels, serum ferritin levels will be compared between two groups by t-test or Mann-Whitney test. Compliance and frequency of side effects will be compared between two groups by Chi-square test or Fischer’s exact test. Intention to treat analysis as well as per protocol analysis will be done for primary variables. For patients who are lost to follow up after 4 weeks, their last Hb values will be used for analysis of primary outcome. Non-responders will be analyzed as per protocol analysis. Level of significance will be P value <0.05.