L-Carnitine Supplementation, Rate of Weight Gain and EED in Children With SAM
Status:
Not yet recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
Background:
Burden:
Globally, an estimated 14.3 million under-5 children are severely malnourished. Two-thirds of
them live in Asian countries, including Bangladesh. Acute malnutrition is an underlying cause
of nearly half of global deaths in under-5 children despite standardized rehabilitation
protocols. It is also associated with high relapse rates following discharge.
Knowledge Gap:
Malnourished children suffer from deficiencies of several essential nutrients. Studies showed
that malnourished children had lower serum carnitine levels and demonstrated its role in the
rate of weight gain in children with severe acute malnutrition (SAM). The consequences of
nutritional impairment can be perilous if carnitine deficiency is coupled with Environmental
Enteric Dysfunction (EED). Recent evidence confirms that EED is characterized by secondary
carnitine deficiency in children. Carnitine deficiency leading to EED may cause childhood
growth faltering and impaired cognitive development. However, evidence on carnitine status
and its consequences in relation to EED in diarrheal children with SAM is very limited in
Bangladesh.
Relevance:
Such lack of information regarding the role of L-carnitine in improving the rate of weight
gain in malnourished children susceptible to EED is an obstacle in limiting the relapse and
adverse consequences of SAM in diarrheal children living in resource-limited countries.
Hypothesis: L- carnitine supplementation for 15 days in children with SAM will improve the
rate of weight gain and biomarkers of EED
Objective:
1. To investigate the role of L-carnitine supplementation on the rate of weight gain among
the children with SAM
2. To investigate the role of L-carnitine supplementation on the duration of the hospital
stays
3. To examine the role of L-carnitine supplementation on EED biomarkers, for instance,
myeloperoxidase (MPO), neopterin (NEO), alpha-1 anti-trypsin (A1AT), kynurenine:
tryptophan (KT) ratio, and citrulline in children with SAM
Methods: This study will be a double-blinded, placebo-controlled randomized clinical trial
Phase:
N/A
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh