Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01705769 |
| Other study ID # |
RPC538 |
| Secondary ID |
CTRI/2012/10/003 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 8, 2012 |
| Last updated |
June 4, 2015 |
| Start date |
October 2012 |
| Est. completion date |
April 2015 |
Study information
| Verified date |
June 2015 |
| Source |
Society for Applied Studies |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
India: Ministry of Science and TechnologySwitzerland: World Health OrganizationIndia: National Research Alliance for Severe Acute Malnutrition, Government of India |
| Study type |
Interventional
|
Clinical Trial Summary
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.
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
- Children randomized to the first intervention arm (Arm 1) will receive a centrally
produced RUTF.
- Children randomized to the second intervention arm (Arm 2) will receive a locally
produced RUTF.
- Children randomized to the comparison group (Arm 3) will receive augmented
Home-Prepared Foods.
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:
- To compare the weight gain (in grams/kg body weight/day) from enrolment till recovery,
or till 16 weeks in those who do not attain recovery, at 16 weeks after recovery.
- To compare the time required to reach recovery (in weeks).
- To determine the incidence and prevalence of diarrhea, ARI and fever during the
treatment phase
- To compare the mortality and hospitalizations during the treatment phase, 16 weeks
after recovery
- To compare the perceptions of families, health care providers and ICDS functionaries
regarding feasibility of use of the feeding regimens in a sub sample from enrolment tom
completion of treatment phase
- To ascertain factors which affect recovery, at 16 weeks post enrolment in those who do
not recover.
- To compare the perceptions of families regarding Anganwadi centre experience at the end
of sustenance phase.
- To compare the proportion of children with weight for height greater than or equal to
-2 SD and absence of oedema feet at 16 weeks after recovery (or 32 weeks after
enrolment for those who do not recover)
- To document the costs of implementing the feeding regimens till end of treatment phase.
This will include:
1. Estimation of costs of human resource and other inputs
2. Estimation of household costs
3. Costs per week per child estimated based on total costs and covered population
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.
