CompletedNot Applicable

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

Bangladesh98 participantsStarted 2021-10-19

Plain-language 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

Who can participate

Age range

9 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diarrheal children with SAM aged 9-24 months * Signed informed consent by the guardian/caregivers Exclusion Criteria: * Severe sepsis or Septic shock * Patients already taking medications containing L- carnitine * Children with Tuberculosis * Children with congenital defects or chromosomal anomalies * Children with a diagnosed case of Thalassemia * Children with an active or previous history of convulsion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of weight gain

Timeframe: Baseline to 15th day of treatment

Trial details

NCT IDNCT05083637

SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-30

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