Evaluating Fingermillet and Beetroot as nutritional support in children with Sickle cell disease

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Dietary Intervention of Fingermillet and Beetroot as adjunct therapy: Participants in the control group or comparative group will continue to receive routine care without the study specific dietary intervention.The values of specified parameters and biomarkers levels will be estimated from Baseline to three months and si Xmonths of period. Intervention2: Dietary intervention of Finger millet and Beetroot as adjunct therapy along with routine diet: Participants in the comparator group will receive routine standard care for sickle cell disease as prescribed by the treating physician. They will not receive the study specific finger millet and beetroot dietary intervention. Routine medications including hydroxyurea where clinically indicated and other standard supportive care will continue as per the treating physicians advice. Control Intervention1: Routine diet or Standard care: Participants randomized to the intervention group will receive a standardized dietary intervention consisting of finger millet (Eleusine coracana) and beetroot (Beta vulgaris) in addition to their routine care. The quantities of finger millet and beetroot will be prescribed according to the participants age group and administered for the predefined intervention period. Finger millet will be provided in an age‐appropriate prepared form such as porridge roti idli or dosa using the prescribed quantity of finger millet. Beetroot will be provided in an age appropriate form such as juice or cooked beetroot using the prescribed quantity. The dietary intervention will be incorporated into the participants usual diet and will not replace routine meals or prescribed medical treatment. The intervention quantities will be standardized at baseline. Caregivers will be provided with standardized measuring utensils and will receive training from the study nutritionist regarding the preparation quantity and administration of the dietary intervention. Adherence to the dietary intervention will be monitored throughout the study period. Participants in the control group or comparative group will continue to receive routine care without the study specific finger millet and beetroot dietary intervention like the cases group. Both groups will continue their prescribed standard medical care such as hydroxyurea etc throughout the study. CONDITION: Health Condition 1: D573‐ Sickle‐cell trait PRIMARY OUTCOME: Clinical ‐ ; No. of blood transfusions ; Hematological ‐ ; Hb ; Biochemical ‐ ; Iron ; Calcium ; Biomarkers‐ ; 3‐‐Nitrotyrosine ; CalprotectinTimepoint: Clinical ‐ ; No. of blood transfusions ; Hematological ‐ ; Hb ; Baseline and after 3 months ; 6 months of dietary intervention ; ; SECONDARY OUTCOME: Anthropometric ParametersTimepoint: Baseline and after 3 months ; 6 months of dietary intervention INCLUSION CRITERIA: Confirmed diagnosis of HbS and Variants.
Epistemonikos ID: 441210d222628ddc8dadf6fe12d3accb55d42145
First added on: Oct 08, 2026