Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
This project aims to assess the efficacy of three options under consideration in India for home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a multi-center randomized controlled trial to determine the efficacy of two community-supported home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and will have enough statistical power to detect a 15% or greater difference in recovery rates between either one of the intervention groups compared with comparison group.
Full description
India accounts for over half the global burden of severe acute malnutrition (SAM) in the world. While it is important to accelerate efforts to prevent SAM, effective management of children suffering from it is critical for reducing child mortality and achieving MDG1 and MDG4.
Available evidence mostly from studies in Africa suggest that home based management of uncomplicated SAM with Ready to Use Therapeutic Foods (RUTF) is at least as efficacious as facility-based management and that locally produced RUTF is as efficacious as centrally produced RUTF. More evidence on efficacy and effectiveness of home based management using RUTF is needed to decide if this intervention offers substantial advantages over home-prepared foods in the Indian settings. Additionally, there is a demand to generate evidence of efficacy of locally produced RUTF as compared to that of centrally produced RUTF. These issues can only be resolved through a well designed randomized controlled trial.
This project therefore aims to assess the efficacy of three options under consideration in India for home management of SAM. The investigators propose to conduct a multi-center randomized controlled trial to determine the efficacy of two community-supported home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and will have enough statistical power to detect a 15% or greater difference in recovery rates between either one of the intervention groups compared with the comparison group.
Participants: The study will be conducted in three sites - urban slums and resettlement colonies in the national capital region, rural (predominantly tribal) Rajasthan, rural and urban Tamil Nadu. Field workers will survey the study area to measure mid-upper arm circumference (MUAC) in children 6 to 59 months of age and refer children with MUAC less than 13 cm to a study clinic. At the study clinic, anthropometric measurements will be taken and children with weight for height less than -3 SD of the WHO standards or oedema of both feet will be offered participation in the study.
Intervention and Comparison Regimes for Home Management of SAM
The amount of food advised for each child in all the 3 study arms are calculated to provide 175cal/kg body weight per day. These foods will be given to children from the time of enrollment until recovery (but not beyond 16 weeks). Caregivers of all enrolled children will receive counseling on frequency of feeding, amounts to be fed, encouraging children to continue breastfeeding and good hygiene practices. Additional support through a volunteer from the community will be provided to mothers who give consent, to assist in feeding the child.
Management Phases: The management will be in two phases:
Treatment Phase: From enrolment until recovery or 16 weeks (whichever is earlier), enrolled children will be provided the foods according to the study group they are randomized to, and counselled on their use.
Sustenance Phase: After completion of the treatment phase, children in all arms will be referred to the closest Anganwadi centre from where he/she will access supplementary foods given to children as a part of the ICDS strategy. The sustenance phase will last for 16 weeks after end of treatment phase.
Outcomes: A trained and standardized team of field workers will conduct weekly anthropometric measurements and also record morbidity, hospitalizations and deaths from enrolment, weekly till recovery or 16 weeks whichever is earlier. In addition, mortality and hospitalization data will be collected at 16 weeks post treatment phase.
The primary outcome will be recovery by 16 weeks after enrollment (defined as achieving weight for height greater than or equal to -2 SD and absence of oedema).
Secondary outcomes will include:
This will include:
The project has been approved by the National Research Alliance for SAM constituted by the Department of Health and Family Welfare, Department of Health Research and Department of Biotechnology. It will be coordinated by Centre for Health Research and Development-Society for Applied Studies. WHO will provide technical support and monitoring for the study implementation as a response to a request from the Alliance. Oversight to the study will be provided by a Technical Advisory group constituted by the Alliance and a Data Safety Monitoring Board. Clearances have been sought from the state governments of Delhi, Rajasthan and Tamil Nadu.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
911 participants in 3 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal