Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05891457 |
| Other study ID # |
PR-21013 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trail study is to measure neurophysiologic parameters to assess the
effect of malnutrition on the peripheral nervous system and their response to treatment in
three categories (SAM, severe wasting, and severe stunting) of childhood malnutrition. 83
under-5 children from three categories of undernourished groups- severe stunting (n=30),
Severe acute malnourished (n=22), wasting (n=31), and 45 age-matched healthy children from
urban/peri-urban areas were enrolled.
SAm were provided with appropriate nutritional therapy/treatment that include supplementation
of a high-calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation.
Egg milk and micronutrient supplementation were for recovery from severe stunting. Wasted
children were treated with suitable local nutritional management (NM), such as infant and
young child feeding practices (IYCF), providing MNP and nutrition education. Wasted children
with medical complications were treated with specialized therapeutic milk (F-75) and those
without medical complications were treated with a suitable local Nutritional Management (NM)
& routine medicines to treat simple medical conditions at community nutrition center (CNC)
with weekly follow up. At day 60 of intervention, children were again brought to icddr,b for
a nerve conduction test.
Description:
The purpose of this study is to measure neurophysiologic parameters to assess the effect of
malnutrition on peripheral nervous system and their response to treatment in three categories
(SAM, severe wasting and severe stunting) of childhood malnutrition. The electrophysiological
properties of peripheral nerves in malnourished under-5 children before and after correction
of severe malnutrition were assed.
This is an exploratory study conducted in icddr,b, Dhaka, Bangladesh. 83 under-5 children
from three categories of undernourished groups- severe stunting (length-for-age Z-scores
<-3), SAM (weight-for-length Z-scores <-3, and/or mid-upper-arm circumference <11.5 cm, with
or without nutritional edema) and wasting (weight-for-length Z-scores (WLZ) <-2) were
enrolled. A total of 45 age-matched healthy children selected as controls. Participants were
identified from urban/peri-urban areas of Dhaka city. After enrolment, participants were
brought to icddr,b Dhaka Hospital and data on socio-economic status, weaning practice,
morbidity, and dietary intake were collected. Nerve electro physiologic parameters assessed
by motor (median, ulnar, fibular and tibial) and sensory (median, ulnar and sural) nerve
conduction studies (NCS) on enrollment.
SAM were treated with appropriate nutritional therapy/treatment that included supplementation
of high calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation.
Egg-milk and micronutrient supplementation were provided for 2 months for recovery from
severe stunting (following standard guidelines for facility based management and recently
conducted community based nutrition intervention studies). As per national guidelines,
children suffering from severe wasting with medical complications were treated with
specialized therapeutic milks (F-75) and those without medical complications treated with a
suitable local Nutritional Management (NM) & routine medicines to treat simple medical
conditions at community nutrition center (CNC) with weekly follow up. Children were monitored
in the community for 2 months. Monthly anthropometry had been done. On day 60 or 2 months of
intervention, children with weight-for-length/height Z-scores ≥-1 and MUAC >115 mm were again
brought to icddr, b for nerve conduction test.
