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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01553877
First received: January 24, 2012
Last updated: January 1, 2013
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Moderately Malnourished Children
Dietary Supplement: Pushti packet
Dietary Supplement: Rice based Ready to Use Complementary Food Supplements
Dietary Supplement: Chick-pea based Ready to Use Complementary Food Supplements
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Acceptability of at least one Ready -to-Use Complementary Food supplement [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pushti Packet Dietary Supplement: Pushti packet
A food composed of roasted rice, roasted lentil, molasses and soybean oil
Other Name: 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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553877

Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01553877     History of Changes
Other Study ID Numbers: PR-10066
Study First Received: January 24, 2012
Last Updated: January 1, 2013
Health Authority: Bangladesh: Ethical Review Committee

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 26, 2014