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

I

International Centre for Diarrhoeal Disease Research (icddr,b)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Moderately Malnourished Children

Treatments

Dietary Supplement: Pushti packet
Dietary Supplement: Chick-pea based Ready to Use Complementary Food Supplements
Dietary Supplement: Rice based Ready to Use Complementary Food Supplements

Study type

Interventional

Funder types

Other

Identifiers

NCT01553877
PR-10066

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

6 to 18 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

Pushti Packet
Active Comparator group
Treatment:
Dietary Supplement: Pushti packet
Rice based Ready to Use Complementary Food Supplements
Experimental group
Treatment:
Dietary Supplement: Rice based Ready to Use Complementary Food Supplements
Chick-pea based Ready to Use Complementary Food Supplements
Active Comparator group
Treatment:
Dietary Supplement: Chick-pea based Ready to Use Complementary Food Supplements

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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