MedTrace Logo

L-Carnitine Supplementation, Rate of Weight Gain and EED in Children With SAM

NCT05083637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-03-07

No results posted yet for this study

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

Conditions

  • Malnutrition

Interventions

DRUG

L- carnitine oral solution

The L-carnitine syrup formulation will be provided to study participant at nutritional rehabilitation unit (NRU) under controlled set-up

OTHER

Placebo

The placebo formulation will be provided to study participant at nutritional rehabilitation unit (NRU) under controlled set-up

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Jinat Alam, MBBS · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • Bangladesh

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083637 on ClinicalTrials.gov