Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02839148 |
| Other study ID # |
PR-16005 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2016 |
| Est. completion date |
April 2018 |
Study information
| Verified date |
August 2018 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will provide a tool for researchers to measure important outcomes in relation to
trial of intervention to reduce or prevent stunting.
Hypothesis: We assume that appetite score will be associated with improvement in growth and
development parameters of children given the nutrition and psychosocial stimulation
intervention
Objectives:
To explore maternal perception regarding childhood stunting To develop and validate an
appetite measuring tool To assess the appetite status of young children To examine the
relationship between appetite score, growth and development, potential biomarkers of
appetite, child food intake and intestinal inflammation of the children.
Methods: In the first phase, a qualitative study will be conducted to explore maternal
perception regarding childhood stunting and to develop a tool- the "Early Childhood Appetite
and Satiety Tool"(ECAST) using mixed method approach (qualitative and quantitative). In the
second phase, a community-based trial will be conducted with 50 stunted children of aged
12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children
(non-stunted).
Description:
The stunted children will receive an intervention package which includes food supplementation
(FS) with one egg and 150 ml of whole milk supplementing the usual home diet, 6 days a week
for 3 months; psychosocial stimulation (PS) for 6 months, and routine clinical care monthly
for 6 months. The control children will receive routine clinical care but no FS and PS.
Routine clinical care includes micronutrients powder, de-worming, health and nutrition
education and immunization. All children will be assessed for appetite score (ECAST score)
and anthropometry-at baseline then monthly for 6 months; food intake at baseline then monthly
for 3 months, and cognitive development using Bayley Scales of Infant and Toddler
Development, third version (Bayley-III) on enrolment and at 3 and 6 months of enrolment.
Blood samples will be collected to examine gut hormones, complete blood count and haemoglobin
percentage.
Stool samples will be collected for routine examination and stool biomarkers. Urine sample
will be collected for screening urinary tract infection. All the specimens will be collected
at baseline and at 3 and 6 months of enrollment.
Outcome measures/variables:
The primary outcome:
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted
children.
The secondary outcomes are:
-Association of appetite score with growth and development with potential biomarkers of
appetite with child food intake and intestinal inflammation of the children.
