Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
Primary Purpose
Moderately Malnourished Children
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Pushti packet
Rice based Ready to Use Complementary Food Supplements
Chick-pea based Ready to Use Complementary Food Supplements
Sponsored by
About this trial
This is an interventional prevention trial for Moderately Malnourished Children
Eligibility 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.
Sites / Locations
- ICDDR,B
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Pushti Packet
Rice based Ready to Use Complementary Food Supplements
Chick-pea based Ready to Use Complementary Food Supplements
Arm Description
Outcomes
Primary Outcome Measures
Acceptability of at least one Ready -to-Use Complementary Food supplement
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01553877
First Posted
January 24, 2012
Last Updated
January 1, 2013
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT01553877
Brief Title
Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
Official Title
Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderately Malnourished Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pushti Packet
Arm Type
Active Comparator
Arm Title
Rice based Ready to Use Complementary Food Supplements
Arm Type
Experimental
Arm Title
Chick-pea based Ready to Use Complementary Food Supplements
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Pushti packet
Other Intervention Name(s)
A food composed of roasted rice, roasted lentil, molasses and soybean oil
Intervention Description
A food composed of roasted rice, roasted lentil, molasses and soybean oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Rice based Ready to Use Complementary Food Supplements
Intervention Description
A rice based diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chick-pea based Ready to Use Complementary Food Supplements
Intervention Description
A chick-pea based diet.
Primary Outcome Measure Information:
Title
Acceptability of at least one Ready -to-Use Complementary Food supplement
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
ICDDR,B
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
12. IPD Sharing Statement
Citations:
PubMed Identifier
24972632
Citation
Ahmed T, Choudhury N, Hossain MI, Tangsuphoom N, Islam MM, de Pee S, Steiger G, Fuli R, Sarker SA, Parveen M, West KP Jr, Christian P. Development and acceptability testing of ready-to-use supplementary food made from locally available food ingredients in Bangladesh. BMC Pediatr. 2014 Jun 27;14:164. doi: 10.1186/1471-2431-14-164.
Results Reference
derived
Learn more about this trial
Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
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