Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in 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: Moderately Malnourished Children
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1212
    • Icddr,b

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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

• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

General Publications

• 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.

Study record dates

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: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: PR-10066