Effects of Three Feeding Regimens on Recovery of Uncomplicated Severely Acute Malnourished Children (SAMPOORNA)

June 4, 2015 updated by: NBhandari, Society for Applied Studies

To Evaluate the Impact of Three Feeding Regimens on the Recovery of Children From Uncomplicated Severe Acute Malnutrition (SAM) in India and to Use the Evidence to Inform National Policy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
911

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110062
        • Centre for Health Research and Development, Society for Applied Studies
    • Rajasthan
      • Udaipur, Rajasthan, India, 313004
        • Action Research & Training for Health (ARTH)
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632002
        • Christian Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 6 to 59 months
  • SAM, defined as Weight for height less than -3 SD of WHO standard or oedema of both feet or both.

Exclusion Criteria:

  • Complicated SAM defined as child with SAM having signs of severe illness requiring hospitalization
  • Known allergy to animal milk or peanuts
  • Likely to leave the study area permanently in the next 16 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RUTF-Centrally produced
Ready to Use Therapeutic Food-Centrally produced by an Indian company
Other: Ready to Use Therapeutic Food-Centrally produced
Ready to Use Therapeutic Food-Centrally produced by an Indian company.
Experimental: RUTF-Locally produced
Ready to Use Therapeutic Food-Locally produced by the study team at each study site
Other: Ready to Use Therapeutic Food-Locally produced
Ready to Use Therapeutic Food prepared by the study team
Active Comparator: High energy and micronutrient rich foods
High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them
Other: High energy and micronutrient rich foods
High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Recovery by 16 weeks after enrollment (defined as achieving weight for height greater than or equal to -2 SD and absence of oedema of both feet)
Time Frame: Weekly till recovery or 16 weeks after enrollment, whichever is earlier
Weekly till recovery or 16 weeks after enrollment, whichever is earlier

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mortality and hospitalizations
Time Frame: Weekly till 16 weeks or recovery and at end of sustenance phase
Weekly till 16 weeks or recovery and at end of sustenance phase
Rate of weight gain (grams/kg body wt/day)
Time Frame: From enrollment till recovery or 16 weeks whichever is earlier
From enrollment till recovery or 16 weeks whichever is earlier
Time required to reach recovery
Time Frame: From enrollment till recovery or 16 weeks whichever is earlier
From enrollment till recovery or 16 weeks whichever is earlier
Íncidence and prevalence of diarrhea, ARI and fever during treatment phase
Time Frame: From enrollment till recovery or 16 weeks whichever is earlier
From enrollment till recovery or 16 weeks whichever is earlier
Proportion of children with weight for height greater than or equal to -2 SD and absence of oedema of feet
Time Frame: At the end of sustenance phase
At the end of sustenance phase
Cost of three feeding regimens
Time Frame: Enrollment to end of treatment phase
Enrollment to end of treatment phase
Feedback from families, health care providers and ICDS functionaries about the feeding regimens regarding perceptions and feasibility of use
Time Frame: Enrollment to end study
Enrollment to end study
Factors which affect recovery
Time Frame: At 16 weeks post enrolment in those that have not recovered
At 16 weeks post enrolment in those that have not recovered
Perception of families regarding anganwadi centre experiences at the end of sustenance phase
Time Frame: from end of treatment phase to end of sustanence phase
from end of treatment phase to end of sustanence phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Society for Applied Studies

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Health Organization
Christian Medical College, Vellore, India
Arth

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nita Bhandari, MD, PhD, Centre for Health Research and Development, Society for Applied Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RPC538
  • CTRI/2012/10/003054 (Registry Identifier: Clinical Trial Registry - India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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