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

Phase 2

Completed

• Conditions: Moderately Malnourished Children
• Interventions: 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

• Registration Number: NCT01553877
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-24
• Primary Completion: 2012-02
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-14
• Study Completion: 2012-05
• Last Update Submitted: 2013-01-01
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pushti Packet	Pushti packet	-
Rice based Ready to Use Complementary Food Supplements	Rice based Ready to Use Complementary Food Supplements	-
Chick-pea based Ready to Use Complementary Food Supplements	Chick-pea based Ready to Use Complementary Food Supplements	-

Primary Outcome Measures

Name	Time	Method
Acceptability of at least one Ready -to-Use Complementary Food supplement	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.

Trial Locations

Locations (1)

ICDDR,B; 🇧🇩 Dhaka, Bangladesh