Moderately Malnourished Children Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | May 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Months to 18 Months |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | ICDDR,B | Dhaka |
| Lead Sponsor | Collaborator |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh |
Bangladesh,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |