Health Condition 1: E440- Moderate protein-calorie malnutrition
Conditions
Interventions
Intervention1: MDCF-1, MDCF-2 , MDCF-3, MDCF-4: Trial1 : Name : MDCF 1: Finger millet based Intervention
Details: Each enrolled healthy child will receive a finger milletâ??based intervention of 100 g
Sponsors
Indian Council of Medical Research ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Trial 1 Cluster Randomized Controlled Trial Children eligible for Trial 1 will be apparently healthy infants aged 9 to 15 months at the time of enrolment, residing within the catchment areas of the selected Anganwadi Centers. Eligible children must not be severely undernourished, defined by a weight for length z score greater than minus two and less than plus one at baseline. Apparent health status is defined as the absence of any acute or chronic medical illness at the time of enrolment. Minor, self limiting conditions such as mild cough, common cold, or mild diarrhoea will not be considered exclusion criteria, provided the child is clinically stable and follow up is feasible. These criteria aim to include children who are representative of the general Anganwadi Center population while ensuring safety and reliable follow up throughout the intervention period. Trial 2 Individual Randomized Controlled Trial For Trial 2, eligible participants will be children aged 9 to 15 months diagnosed with moderate acute malnutrition. Moderate acute malnutrition is defined as a weight for length z score between minus three and minus two or a mid upper arm circumference between one hundred fifteen millimetres and one hundred twenty five millimetres, confirmed through two independent measurements. Children must be free from acute medical complications requiring inpatient care and should have no prior history of severe acute malnutrition, nutritional edema, or diagnosed chronic illnesses. Children with known food allergies that may interfere with safe consumption of the study foods will be excluded. In addition, families must intend to remain in the study area for the twelve month study duration, and written informed consent must be obtained from the parent or legal guardian.
Exclusion criteria
Exclusion criteria: Trial 1 â?? Cluster Randomized Controlled Trial Children will be excluded from Trial 1 if they meet any of the following criteria. Children with acute malnutrition, defined as a weight for length z score less than minus two or the presence of bilateral pitting edema, will not be eligible for participation. Any child identified with severe acute malnutrition at baseline will be referred to the nearest local health facility for appropriate treatment to ensure ethical and clinical safety. Children with chronic illnesses or congenital disorders that may affect growth or nutrient absorption, such as congenital heart defects, cerebral palsy, or cystic fibrosis, will be excluded. Children with a known or reported allergy or intolerance to any ingredient used in the study foods, including peanut allergy, will also be excluded. In addition, children presenting with an existing acute febrile illness at the time of enrolment will not be eligible for inclusion. Trial 2 â?? Individual Randomized Controlled Trial Children will be excluded from Trial 2 if they meet any of the following conditions. Children diagnosed with severe acute malnutrition, defined as a weight for length z score less than minus three or the presence of bilateral pitting edema, will be excluded. Any child identified with severe acute malnutrition at baseline will be referred to the nearest local health facility for appropriate treatment to ensure ethical safety. Children with chronic medical conditions, including but not limited to untreated tuberculosis, congenital heart disease, severe developmental disorders, or any condition known to affect growth or nutrient absorption, will not be eligible. Children with known or reported food allergies to any ingredients used in the study foods, such as peanut or milk allergy, will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trial 1 Change in Weight-for-Age Z-Score (WAZ) from Baseline (0day) to 12 Months of supplementation Trial 2 Change in Weight-for-Length Z-Score (WLZ) from Baseline (0day) to 6 Months of supplementation Timepoint: Time points: 0 Day, 15 days , 30 days, 60 Days, 90 days, 120 days , 150 days , 180 days, 270 days, 360 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota composition, microbial maturity, gut inflammation, immune biomarkers, and caregiver-reported adherence and acceptabilityTimepoint: Time-points: Time points: 0 Day, 15 days , 30 days, 60 Days, 90 days, 120 days , 150 days , 180 days, 270 days, 360 days | — |
Countries
India
Contacts
Public ContactDr Hemant Mahajan
ICMR National Institute of Nutrition
Outcome results
None listed