Daily versus alternate day oral iron supplementation in children between 6-59 months age with iron deficiency anaemia: Randomized controlled multi-centric study

Primary purpose of this randomized controlled multi-centric trial is comparison of two dose frequency of oral iron therapy in children between 6 to 59 month age with iron deficiency anaemia. One arm will receive daily oral iron for 3 months and another arm will receive alternate day oral iron for 6 months. This will help in dose equivalence of oral iron in two groups. The study hypothesis is that alternate day oral iron therapy in children with iron deficiency anaemia is more effective compared to daily oral iron therapy. Children between 6 to 59 months age with mild to moderate iron deficiency anaemia IDA) as defined by WHO and with serum ferritin less than 30 ng/ml attending OPD  will be included. Children with thalassemia trait, syndromic children, children with physical, cognitive & mental disability, children with chronic illnesses, severely malnourished children  and children who have received a blood transfusion will be excluded. Children fulfilling inclusion criteria will be enrolled after due consent from parents. A single 5-7 ml venous blood sample will be taken for investigations at three time points, at baseline, after 3 months and after 6 months.  The laboratory tests which will be conducted at all three timepoints: CBC, serum ferritin, CRP, serum iron studies and serum hepcidin. Sample for Hb-HPLC or Hb electrophoresis before enrolment to study (as part of baseline sampling) will be taken to exclude children with thalassemia. Sample at 03 months and 06 months will be taken after 03 days of stopping Iron therapy to avoid hepcidin surge post oral iron therapy. Sample processing will be done in pathological laboratories in situ. Sample for serum hepcidin will be stored at  minus 20 degree C and transported to nodal centre for processing in batches. All enrolled children more than 12 months of age will receive one dose of albendazole (to ensure deworming) before starting oral iron. Control arm will receive 3mg/kg/day of oral iron (Preparation Colloidal iron 80 mg/5 ml elemental iron with RDA of Folic acid (200 µg) and B12 (2 µg) as once daily dose for three months. Iron syp of same batch will be procured and distributed to all the participating centres. Experimental arm will receive 3mg/kg of oral iron as OD dose on alternate days for a total for 6 months. Primary outcome will be prevalence of IDA at end of oral iron therapy in two arms. Secondary outcome will be comparison of Hb, serum ferritin, serum iron studies and serum hepcidin at baseline, at three months and at 6 months. Research fellows will be trained before enrolment with respect to data collection. Compliance will be ensured and marked and GI side-effect profile will be noted by research fellows using telephonic calls on weekly basis. Children experiencing pain abdomen, diarrhoea, dyspepsia and vomiting greater than grade 3 as per common terminology criteria for adverse events (CTCAE) will be taken out of study. Data will be collected in excel sheet and analyzed using suitable statistical tests.