Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh

January 1, 2013 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh
The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • 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

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

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day.

Exclusion Criteria:

  • loss of appetite,
  • oral lesion,
  • congenital anomaly/acquired disorder affecting growth,

  • severe acute malnutrition (SAM) defined by:

    • MUAC < 115 mm or
    • WL < -3 Z score or
    • bipedal edema,
    • persistent diarrhea,
    • tuberculosis,
    • any other chronic illness.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pushti Packet
Dietary supplement: Pushti packet
A food composed of roasted rice, roasted lentil, molasses and soybean oil
Other Names:
  • A food composed of roasted rice, roasted lentil, molasses and soybean oil
Experimental: Rice based Ready to Use Complementary Food Supplements
Dietary supplement: Rice based Ready to Use Complementary Food Supplements
A rice based diet.
Active Comparator: Chick-pea based Ready to Use Complementary Food Supplements
Dietary supplement: Chick-pea based Ready to Use Complementary Food Supplements
A chick-pea based diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of at least one Ready -to-Use Complementary Food supplement
Time Frame: 7 days
At least one of the experimental Ready -to-Use Complementary Food supplement will be acceptable to the study participants for prevention of malnutrition. The acceptability will be assessed by a 7-point Hedonic scale.
7 days

Collaborators and Investigators

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

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

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

January 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 1, 2013

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-10066

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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