Development and Field Testing of Ready-to-use-therapeutic Foods Made of Local Ingredients in Bangladesh for SAM Children

February 10, 2022 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh

Development and Field Testing of Ready-to-use-therapeutic Foods Made of Local Ingredients in Bangladesh for the Treatment of Children With Severe Acute Malnutrition

Around 0.5 million under-five children are currently suffering from severe acute malnutrition (SAM) in Bangladesh and are at risk of death. Children with SAM and complications should be treated in a health care facility. It is imperative, however, to manage children with SAM but without any complications in the community. This requires a ready-to-use-therapeutic food (RUTF) that conforms to standard recommendations on its composition. The prototype RUTF is peanut based, made outside Bangladesh, and has to be imported. By developing a RUTF using local food ingredients, test it for acceptability and efficacy in the treatment of children with SAM, hopefully make the treatment of SAM cost-effective and sustainable.

Hypothesis: Does the locally developed ready-to-use-therapeutic foods (RUTFs) demonstrate similar or better acceptability and efficacy in the treatment of children suffering from severe acute malnutrition (SAM) when compared to the prototype RUTF (Plumpynut)?

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

Childhood malnutrition continues to be a significant public health problem in the world, especially in Asia. Acute malnutrition and more so, severe acute malnutrition (SAM) among children below five years of age remains a major embarrassment, and impediment to optimal human capital development in Asia. Without access to appropriate treatment, these SAM children are at high risk of death; there are only a few hospitals in Bangladesh and other developing countries with facilities for managing these children appropriately and their coverage is extremely low. In 2008, the Government of Bangladesh published National Guidelines for management of SAM at the facility level. However, these national guidelines have yet to become operationalized and there are very small exploratory initiatives that focus on community-based management of acute malnutrition (CMAM). Under the auspices of the Directorate General of Health Services, a 2007 national consensus meeting on the management of SAM resolved that CMAM along with scaling up facility-based management is essential for Bangladesh but that a local RUTF should be developed to ensure cost-effective and sustainable programs. Absence of a RUTF that is made of locally available food ingredients and hence, relatively inexpensive, is impeding the implementation of programs for community-based management of SAM in the country. The proposed project will develop new and improved recipes of RUTF based on established principles of dietetics and select at least two candidate RUTFs for treating SAM and testing their acceptability and efficacy. The experiments for development of RUTF will be done in ICDDR,B Food Processing Laboratory by the investigators. Experiments, including assessment of the composition of the local food ingredients and the presence of anti-nutrient factors, such as phytate, will be performed in the laboratories of Nutriset in France. Acceptability of the candidate RUTFs by the children as well as by the mothers will be assessed and compared among groups of children, who receive any new two RUTF products and the prototype RUTF (Plumpy'nut). For efficacy trial, the study population will be the children who will come to ICDDR,B hospital with SAM and complications. They will receive the standardized management during the acute/initial phase of treatment in the hospital. After completion of the initial treatment of associated medical complications an appetite test with the standard RUTF will be done. If the child passes the appetite test, the child will be enrolled in the study and subsequent alternate feeds of the child will be replaced with the assigned RUTF. The child will be further observed next day giving the total ration of the assigned RUTF and will be monitored for any possible adverse effects, e.g. skin rash, urticaria from food allergy, abdominal distension, pain abdomen, vomiting, diarrhea or any other significant change in clinical status. If there is no unwanted event and the child eats RUTF eagerly, then the child will be discharged from the hospital with RUTF ration for one week (7- 10 days' ration covering the weekends and any holidays). The RUTFs will be used in a partial double-blind manner. Complete blinding of the three RUTFs might not be possible because of distinctive smell of peanuts in proto type RUTF. Other two candidate RUTFs will be blinded. The code will be kept by the producer of the sachets (Nutriset) and Dr ASG Faruque, Senior Scientist, ICDDR'B, who will not be involved with the study. A team of ICDDR,B staff will be responsible for implementation of the study. All field personnel recruited will be full time for this study and will have prior experience in interview techniques, data collection, and assessment of nutritional status. Before starting field activities, an intensive 5-day training will be given to the supervisors and interviewers. The quality control team supported by investigator(s) will monitor the performance of field personnel through regular observation at the household level and regular checks of data for completeness. The quality control team will independently check the data collection. Errors detected will be corrected immediately in the field. The entire assignment including the report writing will be completed within 24 months after the IRB approval from ICDDR,B and signing of MOU between the UNICEF, Bangladesh, Nutriset and ICDDR,B.

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.
490

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.
  • Phase 2
  • Phase 3

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

  • Bangladesh
      • Dhaka, Bangladesh, 1212
        • International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

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:

  • Children aged 6 to 59 months (either sex)
  • Suffering from Severe Acute Malnutrition (SAM) defined by WHZ <-3 using WHO growth standards 2006 and/or having bipedal edema (nutritional), and/or MUAC <11.5 cm
  • Have completed acute (stabilization) phase management, are clinically well, and have an appetite
  • Additional enrollment criteria will be: no signs of concurrent infection, mothers/caregivers agree to stay in their current address for at least the next three months (for ease of follow-up of the children)
  • Informed written consent obtained from the parent or guardian.

Exclusion Criteria:

  • Failure to obtain Informed consent from parents or caretakers
  • Children without any fixed address
  • Children with tuberculosis (diagnosis based on WHO 2006 guidelines which have been incorporated in the national TB control guidelines of Bangladesh)
  • Any congenital/acquired disorder affecting growth i.e. trisomy-21 or cerebral palsy
  • Children on an exclusion diet for the treatment of persistent diarrhea
  • Having known history of soy, peanut or milk protein allergy.

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: Triple

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-1
Made from local food ingredients
Dietary supplement: RUTF-1
Made from local food ingredients
Experimental: RUTF-2
Made from local food ingredients
Dietary supplement: RUTF-2
Made from local food ingredients
Active Comparator: Plumpynut
Made from peanut
Dietary supplement: Plumpynut
Commercially made from peanut paste

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
Measure Description
Time Frame
Weight gain (g/kg/d)
Time Frame: Initially 3 months for the acceptability trial another 18 months will be required for the efficacy trial
The primary objective of the proposed study will be to develop ready-to-use therapeutic food (RUTF) that will ultimately be used to treat childhood severe acute malnutrition which continues to be highly prevalent in Bangladesh. This will involve selection of candidate recipes of RUTF and testing them for acceptability and efficacy among children and caregivers. The successful candidate recipe of local RUTF is expected to have better weight gain (g/kg/d) in children suffering from Severe Acute Malnutrition (SAM).
Initially 3 months for the acceptability trial another 18 months will be required for the efficacy trial

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.
International Centre for Diarrhoeal Disease Research, Bangladesh

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.
UNICEF
Nutriset

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

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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.
April 1, 2013

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.
December 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.
December 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).
June 26, 2013

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.
June 26, 2013

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.
June 28, 2013

Study Record Updates

Last Update Posted (Actual)

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.
February 11, 2022

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.
February 10, 2022

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

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.
  • PR-11005

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