Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition

This is a randomized clinical trial aimed at evaluating the effectiveness, tolerability and safety of standardized milk-based formulation, standardized non-milk based formulation and a hospital-based formulation in the management of children aged 6 - 59 months with moderate acute malnutrition. Eligible children will be randomized into one of the three intervention arms and given supplementary doses of the formulations at 50% of their daily caloric requirement for a period of four months based on the group of their assignment. The remainder will be obtained from their regular family diets. The clinical features, anthropometric measurements and laboratory parameters of the children will be assessed at baseline. The children will be followed up on two weekly basis for a period of four months during which further clinical assessment, anthropometric measurements and laboratory evaluations will be performed. The outcome measures will be determined based on "per protocol analysis".

Sex

All

Minimum age

6 Months

Maximum age

59 Months

Inclusion Criteria:

1. Children aged 6 - 59 months with moderate acute malnutrition (weight-for-height between -2 and -3 Z scores or mid upper arm circumference of 11.5 cm - 12.5 cm).
2. Children whose parents/guardian consent to their participation and agree to bring the children/wards to the health facility throughout the period of the study.

Exclusion Criteria:

1. Children with chronic illnesses that may affect growth {(cardiac disease, renal disease, tuberculosis (chronic cough, history of contact with an adult with chronic cough, poor growth, chest infection not responding to antibiotics) liver disease, HIV/AIDS}
2. Children with feeding difficulties eg. Gastroesophageal reflux diseases, cleft palate
3. Children with diarrhoea
4. Children with neurological diseases eg. Cerebral palsy
5. Children less than 6 months or more 59 months of age

• BACKGROUNDSeetharaman N, Chacko TV, Shankar SLR, Matthew AC. Measuring malnutrition - the roles of Z scores and the composite index of anthropometric failure. Indian Journal of Community Medicine. 2007; 32 (1): 35-39.
• BACKGROUNDVijay DW, Bhawesh RD. Ready to use therapeutic food (RUTF): An overview.. Advances in life Sciences and Health. 2015; 2 (1): 1-15.
• BACKGROUNDChoudhury N, Ahmed T, Hossain MI, Islam MM, Sarker SA, Zeilani M, Clemens JD. Ready-to-Use Therapeutic Food Made From Locally Available Food Ingredients Is Well Accepted by Children Having Severe Acute Malnutrition in Bangladesh. Food Nutr Bull. 2018 Mar;39(1):116-126. doi: 10.1177/0379572117743929. Epub 2017 Dec 19. PMID 29258336