Skip to main content
OpenTrials
Completed

NCT Number: NCT01553877

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

ICDDR,B

Dhaka, Dhaka Division, 1212, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pushti packet

Dietary Supplement

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

Rice based Ready to Use Complementary Food Supplements

Dietary Supplement

A rice based diet.

Chick-pea based Ready to Use Complementary Food Supplements

Dietary Supplement

A chick-pea based diet.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 14, 2012
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.